Join Rakuten Aspyrian

IMPORT/EXPORT LOGISTICS MANAGER

Location: San Mateo, CA

Rakuten Aspyrian is in need of an experienced Import/Export Logistics Manager. This is a key position to streamline our global supply chain efforts and act as a liaison to support logistics-related activities such as import/export for CMC, Clinical, and Global Supply Chain. The Import/Export Logistics Manager will serve as an integral part of the Supply Chain team and will report to the Associate Director of Global Supply Chain. We are looking for a professional who has extensive experience in the biotech/pharmaceutical industry, and who has specific experience in logistics activities related to import/export, licenses, tariffs, insurance, VAT reclaim, and importer of record services. The Import/Export Logistics Manager will additionally focus on improving our relations with existing vendors (i.e. 3PLs and couriers) while finding new suppliers who can meet our needs more efficiently. We are a forward thinking organization with expansion on the horizon. Rakuten Aspyrian is looking for someone who is willing to grow with our company and willing to meet the challenges.

Key Duties and Responsibilities
• Manage the import/export process and ensure compliance with U.S., EU, Asia Pacific and other foreign government laws and regulations.
• Oversee the completion of paperwork and transactions associated with international distribution in a timely manner.
• Assist CMC, Clinical, and Global Supply Chain on matters like tariffs, insurance, VAT, proforma or commercial invoices, import/export licenses, and quotas.
• Advise Finance, where appropriate, on financially significant / relevant activities, such as VAT and customs refunds / payments, key vendor milestone payments, and contract terms for future logistics agreements. Specific activities include: shipping logistics budgeting, commercial invoices statements, retrieving C88 receipt for VAT reclaim, and authorization of shipment charges and invoices.
• Work with manufacturers and distribution centers to ensure proper documentation is in place to avoid customs delays.
• Responsible for the shipping logistics of Rakuten Aspyrian intermediates, drug substance and drug product.
• Establish a good working relationship with Rakuten Aspyrian couriers.
• Tracking and providing shipment updates of critical shipments to SMEs. In the event of shipment disruptions, develop contingency plans or facilitate expedited shipments.
• Create, revise and route to completion import/export logistics procedures and forms
• Executes and oversees tasks related to Importer of Record (IOR) activities such as regulatory requirements, product integrity, duties and taxes.
• Optimize shipment routes to reduce lead-times, shipping costs, and duties.
• Establish partnerships with 3PL’s and distribution centers in order to ensure a robust global logistics network. In addition, develop KPI metrics to monitor and analyze logistics effectiveness.
• Categorize shipments according to harmonized tariff systems and consult with customs agents to facilitate customs clearance.

Desired Education, Skills and Experience

• Bachelor’s Degree in Business, Supply Chain Management or related field
• Knowledge of Trade compliance elements (i.e. HTS Codes, Export Classification Commodity Numbers)
• CPIM certification preferred
• 7+ years’ experience in logistics, distribution, and import/export.
• 5+ years’ experience in Biotech/Pharma industry
• Outstanding negotiation skills
• Successful work experience as an Import/Export Manager
• Excellent organizational skills and ability to meet deadlines
• Strong organizational and project management skills, including ability to multitask and organize/track information
• Previous experience with combination drug-device studies, and/or global clinical trial experience a plus

Location: San Mateo, CA
Department: Global Supply Chain
Type: Full-time
Experience: Senior

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VP/HEAD OF GLOBAL STATISTICAL SCIENCES

Location: San Mateo, CA

Rakuten Aspyrian, Inc., is a privately funded, clinical stage Biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Aspyrian has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Aspyrian plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform.

Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses.

Rakuten Aspyrian is currently sponsoring a global Phase 3 multicenter clinical study to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy in patients with other cancer types.

Given the rapid progression of the clinical studies, we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.

Key Duties and Responsibilities

  • Continue to build the current team (biostatistician, statistical programmers and data management) and lead the team to support early phase, late phase, and post marketing product development programs with accurate statistical science data.
  • The team members must be able to deliver statistical and analytical direction and recommendations to support product development allowing the execution of multiple development programs, company strategies, and goals.
  • Continue developing, implementing statistical analysis processes, policies, and statistical analysis plans that support company programs including global filings and commercialization.
  • Key member of the Global Portfolio Team providing statistical insight and guidance
  • Maintain strategies, projects and goals that assure data have statistical integrity, adequacy and accuracy.
  • Able to create a team that is able to be a strong strategic partner to all company cross functional teams providing excellent statistical data analysis. This will include life cycle teams and translational research teams.
  • Participating in the ongoing development, refinement and enhancements of departmental SOPs, methodologies and techniques for biostatistics research, analysis and reporting
  • Able to represent function at regulatory meetings, inspections/audits, and Company partnerships internal and external.
  • Identify study-level vendor requirements and participate in the evaluation, selection and management of analytical vendors
  • Maintain informed of the area of expertise as it relates to products and programs.
  • Support from the function’s perspective for all products, health economics, outcomes research projects, due diligence, regulatory responses, congresses, and publications.
  • Assuming statistical responsibility for major segments of each project which may include authoring protocol statistical analysis sections and statistical analysis plans and manage study randomization code.
  • Able to demonstrate and help maintain the company’s values, mission, and culture to assist in creating a great place to work.
  • Able to create and lead a cohesive and collaborative team and resource the unit appropriately.
  • Able to create and manage team budget to remain aligned with company budget.
  • Works effectively and collaboratively with colleague toward achieving corporate goals.
  • Strong ability to influence and listen which leads to an efficient team.
  • Leads independently in areas of high experience and expertise.
  • Strong organizational skills, able to analyze large data quickly, detail oriented and adapts in a dynamic, and fast paced global environment.
  • Leads self and team in a positive and respectful manner.
  • Demonstrate ownership of deliverables, takes initiative and hold self and others accountability.
  • Enjoys mentoring and coaching when warranted (direct reports and peers).
  • Ability to interact as an effective function leader who is a team player encouraging collaboration in a multifunctional and multidisciplinary team setting.
  • Good communication skills, written, verbal, and presenting with credibility and confidence.
  • A strategic thinker that is able to evaluate and analysis data that facilitates to a scientific decisions or recommendations.
  • Seeks feedback to continuously grow.
  • Able to appropriately escalate and deescalate concerns with stakeholders.
  • Other duties as assigned (always end the essential functions section with this bullet)

Desired Education, Skills and Experience

  • PhD + 7 years’ experience or Masters Degree + 10 years’ experience in statistics/biostatistics (PhD is preferred).
  • Sound knowledge of ICH-GCP and other relevant standards and guidelines.
  • Must demonstrate sound knowledge and experience in all phases of drug development knowledge of oncology, preferred at least 6 years experience on product development or life cycle teams.
  • Proven experience in the principles and techniques of data analysis, interpretation and clinical relevance.
  • Experience in creative clinical trial statistical designs.
  • Proven experience in interactions with regulatory authorities including NDA/BLA submission experience to FDA and EMA, also PMDA preferred; experience leading discussions with regulatory authorities and health authorities.
  • Experience managing CROs and external partners to ensure high quality, on time and on budget statistical outputs.
  • Proven track record of meeting or exceeding objectives and goals.
  • Strong analytical and problem-solving capabilities and skills.
  • Experience and valued member of cross-functional product development teams and life cycle teams.
  • Good knowledge of ICH Guidelines, FDA safety regulations, or EMA regulations.
  • Experience in management of direct or indirect reports.
  • Willingness and ability to travel domestically or internationally as required.

Location: San Mateo, CA
Department: Clinical
Type: Full-time
Experience: Director

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VICE PRESIDENT/HEAD OF GLOBAL CLINICAL OPERATIONS

Location: San Mateo, CA

This position will report to and work under the supervision of the Chief Medical Officer.

The VP/Head of Global Clinical Operations will be a key leader with responsibility for executive oversight and overall management of all Rakuten Aspyrian clinical study programs and overall trial conduct and be a executive member of the product development team.

This position will work closely with the Chief Medical Officer, the Clinical Operations Team, Medical Directors, Field Trainers, Data Management, Biostatistics, Clinical Supplies Management, Quality Assurance, Clinical Development, Medical Writing, and Program Management to ensure operational implementation of clinical trials to maximize efficiency, contain execution costs, and meet timelines.

Key areas responsibilities will include coordinating and leading the clinical operations functions, study planning, financial oversight, vendor management, managing trial and program timelines and ensuring GCP compliance and providing expertise and strategic guidance as an executive member of the product development team.

The ideal candidate will have a minimum of 20 years of direct experience overseeing all phases of global clinical trials, performing effectively as a member of the senior management team, managing cross-functional teams and managing CRO/vendor relationships. Global phase 3 oncology trial experience is highly preferred. Combination drug/device experience is a plus.

 

Key Duties and Responsibilities

  • Provide executive oversight of current and future global clinical programs for various oncology indications from Phase 1 to NDA/BLA approval
  • Provide direct oversight and management of operations and personnel involved in clinical operations, data management, biometrics, medical writing and other functional groups as assigned
  • Provide operational and clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development
  • Develop clinical timelines and budget forecasts and be accountable for tracking and delivering accordingly
  • Review master service agreements, statements of work, and quality agreements relating to clinical operations
  • Provide oversight of global CROs and vendors from identification to selection to close of contracts
  • Participate in developing and providing input to protocols, annual safety reports, Investigator Brochures, clinical study reports, publications/presentations and regulatory submissions
  • Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices
  • Plan clinical headcount and hiring needs to meet program workload demands
  • Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs
  • Lead initiatives to build clinical department infrastructure
  • In collaboration with QA, ensure that clinical trials are conducted in compliance with applicable regulatory requirements and inspection-ready
  • Represent/advocate for clinical operations needs/resources at a senior management level
  • Other duties as assignedDesired Education, Skills and Experience
  • Degree in the life sciences or related field
  • At least 20 years of clinical operations experience in a pharmaceutical/biotech environment, including global experience. At least 5 years within a similar role as listed in this job description.
  • Global clinical trial management experience (specifically Phase 3 oncology) highly preferred
  • Experience managing CROs and vendors throughout entire clinical operations life cycle
  • Proven success participating in cross-departmental (senior management, regulatory, QA, CMC, program management, finance, business development, pharmacovigilance, medical affairs, clinical development, medical writing) clinical strategy, planning and implementation activities
  • Proven success in leading and coordinating cross-functional clinical operations teams (e.g., clinical operations, data management, biostats, clinical supply chain)
  • Direct experience with sponsor, site, and/or vendor preparation for and participation in regulatory inspections, with global experience preferred
  • Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices
  • Collaborative and team-oriented
  • Demonstrates strong problem-solving, communication, and leadership skills
  • Demonstrates strong organizational, project management, and soft skills
  • Previous experience with combination drug-device studies, a plus
  • Willing to travel to support clinical and corporate activities

Location: San Mateo, CA
Department: Clinical
Type: Full-time
Experience: Senior

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ASSOCIATE DIRECTOR, MEDICAL AFFAIRS

Location: San Mateo, CA

The Associate Director (AD), Medical Affairs is a professional with scientific, clinical and therapeutic area expertise responsible for providing medical support for Rakuten Aspyrian products and compounds in development. He/she is responsible for the execution of medical affairs activities including medical information, providing scientific review for medical and promotional materials, and managing Investigator initiated research (IIRs)/collaborative research proposals, advisory boards and expanded access program(s).

Key Duties and Responsibilities
• Build and manage the medical information capabilities for Rakuten Aspyrian
• Develop and communicate appropriate, quality, compliant and timely responses for Medical Information requests
• Create and maintain a product knowledge database including, but not limited to, written standard response letters and FAQ documents that are scientifically accurate and fair-balanced
• Serve as medical affairs reviewer for promotional and non-promotional scientific materials
• Build and manage the IIR/collaboration research and expanded access/compassionate use program(s)
• Plan, organize and manage medical-scientific events, symposia, advisory boards (eg. KOL selection, meeting materials, and logistics)
• Represent Rakuten Aspyrian at major scientific meetings and conferences. Staff conference booths and develop meeting reviews/reports as assigned
• Perform subject-specific literature reviews to assist the organization in staying abreast of the scientific landscape and developments
• Create and implement policies, SOPs and work instructions governing the operations of medical affairs to meet all compliance standards and regulations
• Establish strong collaborative relationships with key internal and external stakeholders
• Other duties as assigned

Essential Qualifications:
• Advanced degree: PhD, PharmD, or MD
• Minimum 8 years of relevant experience in a pharmaceutical company including a minimum of 6 years’ experience in medical affairs
• Disciplinary expertise in oncology is strongly preferred
• Prior experience with leading/managing medical Information function
• Medical and promotional materials review, and expert knowledge of pharmaceutical medical/promotional regulations and standards is required
• Prior management of IIRs/Collaborative research initiatives is required
• Experience with expanded access programs is preferred
• Prior experience in the planning and implementation of advisory boards is required
• Excellent communication, written, verbal and presentation skills
• Proven ability to review, interpret and present complex scientific data
• Analytical and problem-solving skills; detailed oriented, an independent and critical thinker. Ability to multi-task and shift priorities quickly while working under tight deadlines.
• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction
• Solid ability to foster and maintain strong relations with internal and external customers including investigators and KOLs
• Demonstrated leadership skills
• Must be committed to full compliance with all company SOPs, regulatory requirements, and applicable laws including PhRMA guidelines.
• Proven understanding of the drug development process and prior experience in the pharmaceutical industry
• Proficient with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems
• Excellent communication, time management and project planning skills

Travel Requirements:
• ~25%

Location: San Mateo, CA
Department: Medical Affairs
Type: Full-time
Experience: Director

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ACCOUNTS PAYABLE/ACCOUNTING SPECIALIST

Location: San Mateo, CA

The Accounts Payable/Accounting Specialist will process the day to day accounts payable transactions to ensure that company finances are maintained in an effective and accurate manner. This individual must be reliable, detail oriented, possess strong work ethics and be able to effectively interact with employees, vendors and customers.

Key Duties and Responsibilities
• Review all invoices for appropriate documentation and approval prior to payment
• Sort and distribute incoming mail
• Match invoices to PO and Packing slip
• Prioritize invoices according to payment terms
• Process check requests
• Obtain and enter credit card bills
• Match invoices to checks, obtain all signatures for checks and distribute checks accordingly
• 1099 maintenance
• Process employee expense reimbursement reports
• Respond to all vendor inquiries
• Reconcile vendor statements, research and correct discrepancies
• Assist in month end closing and some accounts recs like Prepaids and Fixed Assets
• Maintain files and documentation thoroughly and accurately, in accordance with company policy and accepted accounting practices
• Assist with ordering materials, supplies, and/or equipment, and the follow through with vendors on shipment and delivery
• May assist staff as to appropriate choices of standard items to be purchased for office and labs
• Follow up on orders to ensure that materials are shipped and delivered on promised dates
• Maintains files of descriptions of available supplies
• Maintains current and accurate files of vendor prices in spreadsheets and accounting software
• Assist with other projects as needed
• Other duties as assigned

Desired Education, Skills and Experience
• Bachelor's in Accounting strongly preferred
• Minimum 2 years of Accounts Payable experience required
• Experience in Great Plains and Concur Accounts Payable Management software preferred
• Experience in Life Sciences preferred
• Must be able to follow standard filing procedures
• Proficient in Excel and Word, 10-key by touch
• Ability to type 60-65 wpm
• Strong problem solving skills, basic accounting principles knowledge, documentation skills, research and resolution skills, data analysis and multi-tasking skills
• Thorough knowledge of applicable accounts payable/general ledger systems and procedures, financial chart of accounts and corporate procedures
• Ability to work independently and with a team in a fast-paced and high volume environment with emphasis on accuracy and timeliness
• Excellent communication skills, organizational skills, with the ability to self- manage and meet deadlines
• Ability to perform mathematical computations such as percentages, fractions, addition, subtraction, multiplication and division quickly and accurately

Location: San Mateo, CA
Department: Finance
Type: Full-time
Experience: Some Experience

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SENIOR MANAGER, BUSINESS AND CORPORATE DEVELOPMENT

Location: San Mateo, CA

As part of the Business Development and Alliance Management team, the Senior Manager of Business and Corporate Development (B&CD) will be responsible for supporting the company’s overall corporate strategy with a focus on marketing and financial analysis, completive strategy, life-cycle management, licensing and partnerships, including due-diligence processes to support corporate growth and diversification of Rakuten Aspyrian’s pipeline.

The Senior Manager of B&CD will work extensively with business development functions, scientific and technical teams, as well as executive management to integrate comprehensive planning, analysis and licensing functions.

The successful candidate will build a network in the academic and biotechnology space to raise awareness of Rakuten Aspyrian’s partnering objectives and capabilities. They will integrate input from various functional areas across the organization to create high-quality, clear and concise due-diligence reports and presentations with recommendations to Rakuten Aspyrian’s Executive Management team.

Key Duties and Responsibilities
• Support strategic planning and analysis of financial models related with product development, commercial strategies, including analysis of internal and external assets under consideration for licensing or partnerships
• Support strategic planning that may include HECON strategy, brand positioning, commercial challenges, launch roadmap strategy, build-up of commercial operations, etc.
• Support life-cycle management activities such as label expansion strategies, evaluating competitive landscape and clinical positioning for Rakuten Aspyrian products.
• Support the Business Development team in the creation of KOL discussion guidelines for in-depth interviews with Key Opinion Leaders and onsite discussions with scientific advisory board to determine the competitive positioning of the company’s products.
• Support the Business Development team in determining the competitive landscape for Rakuten Aspyrian products and develop strategies for positioning and initiating clinical trials.
• Support the executive team in developing Marketing and Branding strategies for ongoing clinical trials and Rakuten Aspyrian products.
• Work with the R&D team to identify, evaluate and champion innovative opportunities and business structures such as new research collaborations, pre-clinical and clinical compounds, and/or technologies for collaboration and licensing
• Responsible for establishing external contacts with Industry and Academia based on company priorities
• Responsible for building and maintaining the Alliance Management database consisting of milestones: financial, clinical, and research updates for existing and future partners
• Support the Business Development group in building and managing a portfolio of partnership opportunities aligned with company goals, from conceptualization to deal completion, and external relationship networks
• In collaboration with Legal, facilitate contract drafting concepts; with R&D, support search and evaluation, licensing and scientific diligence teams; with FP&A, support commercial valuation, forecasts and risk analysis to build business cases
• Build and maintain databases on competitor activities, provide analytic review and context
• Facilitate clear and effective communications with foreign and domestic points of contact
• Other duties as assigned

Desired Education, Skills and Experience
• MBA and/or PhD degree required
• 7+ years of relevant experience with at least 5 years working in the Pharma or Biotech Industry are preferred
• Proven track record in strategy planning and financial analysis of complex programs
• Effective network in the Biopharma industry
• Understanding of the relevant business context of drug development
• Experience in effectively managing industry-academia interactions
• Effective team work, networking and interpersonal skills
• Excellent analytical skills, organization and coordination skills
• Outstanding communication and presentation skills
• Knowledge of scientific, medical, and pharmaceutical terminology
• Experience in document or records management processing
• Travel up to 35% of time required

Location: San Mateo, CA
Department: Corporate and Business Development
Type: Full-time
Experience: Manager

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GLOBAL MEDICAL DIRECTOR, MEDICAL AFFAIRS

Location: San Mateo, CA

The Global Medical Director, Medical Affairs is responsible for the strategic planning, development and execution of a Medical Affairs Plan. He/she will establish and maintain strong medical and professional relationships with key medical/scientific experts in the oncology field. The Global Medical Director, Medical Affairs will collaborate and take medical leadership within cross-functional teams. He/she will be well-versed in the pertinent therapeutic areas of interest to Rakuten Aspyrian and deliver medical and scientific presentations on behalf of the company. The Global Medical Director, Medical Affairs is responsible for the review and approval of medical, promotional and educational materials ensuring medical and scientific accuracy. He/she will be actively involved in lifecycle management initiatives.

Key Duties and Responsibilities
• Accountable for execution and delivery of the Medical Affairs Plan
• Responsible for the implementation and execution of medical strategies to support lifecycle management and pipeline expansion
• Drive medical affairs activities (e.g. advisory boards, training, disease initiatives) and generation of data supporting overall product scientific and business strategy
• Function as a medical expert for Rakuten Aspyrian’s therapeutic areas of interest and products; provide expertise within and outside the organization
• Build and maintain strong relationships with KOLs and HCPs in the therapeutic area of interest; commit to ongoing scientific exchange with customers as appropriate in the field and at medical congresses
• Deliver medical and scientific presentations and provide relevant scientific and technical training
• Represents Rakuten Aspyrian at external meetings including investigator meetings, medical advisory boards and scientific conferences
• Medical lead for review/approval of medical and externally-facing materials
• Provide scientific input into publication strategy
• Review manuscripts for publication, abstracts and posters for presentation at scientific meetings
• Represent the medical affairs function on cross-functional integrated teams
• Support and provide medical input on lifecycle management initiatives
• Identifies data gaps that will inform the IIR program and HEOR initiatives
• Proactively stay abreast of recent scientific/medical literature relevant to therapeutics areas of interest; awareness of competitors' development activities
• Other duties as assigned

Desired Education, Skills and Experience
• Medical Degree (M.D.) with in depth understanding and experience in oncology
• Board certification in oncology or comparable training strongly preferred
• 7 + years of medical affairs experience in the pharmaceutical or biotech industry
• Scientific credibility to lead interactions with KOLs, senior leaders and other external parties
• Excellent written, oral communication, analytical and problem-solving stills
• Experience in collaborating with medical, commercial, clinical, regulatory, health outcomes, and other organizational partners
• Proven strategic thinking related to product development and pipelines
• Strong knowledge of FDA/EMA/PMDA requirements, and pharmaceutical clinical development
• Understanding of Phase 1-4 drug development with proven ability to communicate clinical/scientific data, and generate clinical/scientific documents
• Well organized with strong management, leadership, mentoring and motivational skills
• Ability to work independently and thrive in a fast-paced environment
• Estimated travel ~30%

Location: San Mateo, CA
Department: Medical Affairs
Type: Full-time
Min. Experience: Senior

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SR MANAGER/ASSOC DIRECTOR CLINICAL GCP QUALITY

Location: Japan Tokyo, Japan

The Senior Manager/Associate Director of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the clinical development programs, from start-up through completion of clinical trials, with inspection readiness in mind throughout.   The ideal candidate will advise on company clinical quality strategy and quality management systems and interact directly with the clinical, regulatory and quality teams.  The ideal candidate will have at least 10 years of experience in clinical quality and process improvement and at least one year of clinical auditing experience.  The candidate will have an excellent working knowledge of Good Clinical Practices, and quality requirements and regulations in Japan (PMDA) and other Asia Pacific countries, such as Korea and Taiwan.  In addition, knowledge of other international regulations (e.g. US FDA, EU, ICH E6) and Good Clinical Practices are desirable.

Key Duties and Responsibilities 

  • Provide strategic and operational leadership in the planning and executing of Clinical GCP Quality activities to support companywide and clinical development/clinical trial Quality activities
  • Maintains current knowledge of ever-changing clinical quality guidance and regulations
  • Excellent communication and people skills to ensure a cohesive, collaborative teamwork
  • Demonstrated ability to implement and collaboratively drive company initiatives and policies
  • Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections by regulatory agencies (domestic and international) highly preferred
  • Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close)
  • Successfully demonstrates ability to both conduct and manage site and/or vendor audits as well as direct and guide audit follow-up actions
  • Establish Quality and Cross-Functional SOPs and processes, and associated document controls
  • Serve as local document management system administrator
  • Manage and mentor direct reports
  • Participate in cross-functional meetings between departments and Quality teams
  • Other duties as assigned

Desired Education, Skills, and Experience

  • B.S. Degree in life sciences with advanced degree in a scientific discipline preferred
  • Minimum of 6 years direct experience in GCP Quality Assurance and/or GCP Compliance
  • Minimum of two years of GCP auditing (e.g. clinical site and/or clinical vendor) experience preferred
  • Demonstrated ability to work with various cross-functional teams, including Clinical, Medical, Data Management, Quality, Regulatory and CMC
  • Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents
  • Previous experience with oncology (head and neck cancer), combination drug-device studies, and/or global clinical trial experience is a plus
  • Pharmacovigilance/Safety QA experience a plus
  • Electronic TMF, document, quality, and learning management systems experience
  • Strong organizational and project management skills
  • Professional working proficiency (IRL scale) or above in Japanese and English
  • Willingness to travel up to 30%, but at times may be higher based on business needs

Location: Meguro-ku, Tokyo, Japan
Department: Quality
Type: Full-time
Min. Experience: Senior

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DOCUMENT CONTROL SYSTEM ADMINISTRATOR

Location: San Mateo, CA

As a key member of the quality team, the Document Control System Administrator will be responsible for the execution of document QC processes, controlled document processes, and training processes. The position requires an extremely high attention to detail, hands on experience managing document control processes, and experience in QC review of documents. In addition, this individual will be responsible for configuring and maintaining the electronic document/training system, training users on its use, and expansion of its application as the company grows.  This individual will also be responsible for controlled document management, including establishing and maintaining an appropriate document hierarchy and naming structure by working cross-functionally to ensure documents, including controlled documents and development/research reports, are properly archived and retrievable.

The Document Control System Administrator will oversee and participate in the development, implementation and validation of the Rakuten Aspyrian electronic document management system (EDMS) and electronic quality management systems (EQMS) and serve as the user based Subject Matter Expert (SME) and System Administrator (SysAdmin). This individual will establish, implement and maintain corporate and departmental procedures, protocols, reports, files, training and various other quality and corporate records within the validated EDMS. This position will be the designated System Administrator responsible for establishing/managing file hierarchy and access controls. This position will additionally administer the company electronic learning management system (LMS) and oversee a compliant training program for the company.

Key Duties and Responsibilities
  • May supervise other members of the Documentation Control team
  • Implement, administer and maintain Rakuten Aspyrian EDMS, EQMS and LMS including execution of upgraded software validation and system integrations
  • Manage systems administration for software upgrades, user functionality and support, simple system configuration, ongoing system improvement, software change management, input on system design, validation ad end user training
  • Maintain the EDMS/EQMS/LMS including training users, activating/inactivating users, and system maintenance/optimization
  • Serve as a liaison between the site users and the EDMS/EQMS/LMS system vendors for troubleshooting user issues
  • Coordinate and troubleshoot EDMS/EQMS/LMS errors and issues between IT personnel / service reps
  • Establish operational SOPs for the use, maintenance and security of the EDMS/LMS
  • Perform and manage document QC activities working cross-functionally to ensure accuracy of documents/data and internal consistency, including verification of data to approved source documents, for technical reports, product labelling, and regulatory submission documents.
  • Perform full editorial reviews on various regulatory document types, ensuring correct grammar, mechanics, usage, style, template adherence, etc., according to company style guide and accepted standards.
  • Resolve or verify resolution of document issues with the writers/SMEs regarding QC findings, including verification that all reviewer comments have been addressed.
  • Collaborate with departments (e.g., Clinical Research, Medical Writing, Regulatory Affairs) to facilitate document development, increase SOP/document quality and consistency across documents in specific programs and/or submissions.
  • Coordinate the review, approval, issue and maintenance of controlled documents
  • Manage QA Controlled Document change control for revisions, workflows and assignment of training tasks prior to document effectivity dating
  • Perform document control quality reviews on controlled documents (e.g., SOPs, policies, forms) within the quality document system to verify completeness, legibility, formatting, etc.
  • Manage the periodic review of QA Controlled Documents within the EDMS and ensure compliance to SOP requirements
  • Administer and maintain Rakuten Aspyrian’s training program partnering with SOP authors and hiring managers for training curriculum development, assessment documentation and training reporting
  • Manage the development and delivery of training content for all departments working with Corporate Compliance including interactive software, classroom, and online
  • Manage the document lifecycle management process, which includes providing guidance, formatting, content, management, archival, and retrieval of documents.
  • Manage document archiving according to the retention policy.
  • Manage document logistics during regulatory inspections (e.g., retrieval, logging, review, notifications, and inspection staff).
  • Other duties as assigned

Desired Education, Skills and Experience

  • B.S. in life sciences or other relevant field
  • 2 - 5 years experience performing document QC of regulatory submission documents
  • 5-7 years experience administering electronic document systems
  • Experience with electronic Document/Quality Management Systems required
  • Expert working knowledge with WORD, Excel, Power Point, Adobe (including form building), formatting documents and e-learning content development/ authoring tools
  • Excellent organizational skills and ability to meet deadlines
  • Excellent oral and written communication skills. Ability to communicate across multiple levels of management and cross-functional areas
  • Attention to detail and follow through
  • Must be self-directed and highly motivated
  • Collaborative and interpersonal skills to work in a team environment
  • Ability to work with internal IT and external IT vendors to establish and maintain appropriate system configurations and validation.
  • Ability to travel for purposes of training and system maintenance, as needed
  • Familiar with 21 CPR 210/211 compliance, Systems Development Lifecycle (SDLC), and Information Security requirements
  • Experience in implementing, validating, and maintaining GxP document management, integrated 3rd party, and training systems
  • Experience managing quality-controlled documents, revision workflows and document change control processes
  • Experience in the management and administration of a GXP/compliance training program
  • Experience in implementing and maintaining validated computer systems
  • Experience managing quality-controlled documents, revision workflows and document change control processes
  • Experience in troubleshooting user system problems and solution testing and documentation per IT and QA Change Control requirements
  • Management and administration of a GXP compliance training programLocation: San Mateo, CA
    Department: Quality
    Type: Full-time: Full Time
    Experience: Some Experience

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CLINICAL MEDICAL DIRECTOR

Location: Regional, USA

Rakuten Aspyrian is building its Medical team to support its ongoing and upcoming clinical studies, including a global Phase 3 clinical study. The Senior Medical Director, Medical Director or Associate Medical Director will be a key member of the Medical team with responsibilities to support Aspyrian’s current clinical development program, provide medical expertise to company and project team members, participate as a project team member in new product development and be the medical lead in Phase 1 and Phase 2 trials commensurate with their experience.

The ideal candidate will have an MD, DO, or equivalent degree, hold an active MD &/or DO license, with experience in medical, surgical, or radiation oncology preferred. Additionally, previous industry experience including a working knowledge of drug development process, GCP, ICH guidelines, FDA and EMA regulations as well as direct involvement as an investigator of clinical studies or direct experience in managing clinical operations, medical affairs, and medical safety and monitoring is highly desirable.

The Medical Director may be located anywhere in the USA within a reasonable distance of a major airport,  and will report to the Chief Medical Officer.

Key Duties and Responsibilities

  • Instruct and oversee investigator’s proper performance of Rakuten Aspyrian therapies
  • Provide medical oversight of clinical trials to ensure company standard operating procedures, company directives and regulatory requirements are understood and followed
  • Provide medical expertise to identify new product opportunities and portfolio development
  • Active participation as a member of the clinical development team for early stage products
  • Medical lead for Phase 1 and Phase 2 clinical trials
  • Participate in clinical trial development, including providing input into and/or developing materials such as target product profiles, protocols/amendments and informed consents
  • Work with the Medical Safety and Pharmacovigilance team to perform clinical site medical monitoring as necessary
  • Perform medical review of clinical study reports
  • Attend and present at investigator and company meetings as needed in collaboration with Medical Affairs
  • Manage integration of clinical programs with regulatory strategy
  • Participate in clinical site identification, initiation oversight, and close-out
  • Support the clinical operations group in the management of the CRO’s timely execution of clinical studies
  • Actively participate in interactions with KOLS, in coordination with Medical Affairs
  • Other duties as assigned

 

Desired Education, Skills and Experience

  • An MD, DO, or equivalent degree with active medical license required
  • Oncology experience required, preferably in medical, surgical &/or radiation oncology
  • Expertise in clinical trial design in oncology preferred
  • Experience in Medical Affairs, Medical Safety, Medical Monitoring and Medical lead on Phase 1-2 clinical trials highly valued.
  • Working knowledge of FDA & EMA guidelines for adverse event reporting, Federal Guidelines, GCP, and ICH-GCP
  • Familiar with FDA & EMA guidelines for IND and NDA submissions
  • Understanding of clinical pharmacology with an emphasis on PK/PD of antibodies preferred
  • Working knowledge of biostatistics, data management, and clinical operations' procedures
  • Proficient in the drug development process
  • Strong analytical skills
  • Excellent oral and written communication skills
  • Outstanding interpersonal and team building skills
  • Ability to work independently, analyse, and work with attention to detail, process and prioritize sensitive complex information and problem solve
  • Ability to exercise creativity and judgment
  • Able to travel approximately 50% of the time (including overnight stays) by air, rail, or auto to clinical sites to support US clinical studies.

Location: Regional USA
Department: Clinical Development
Type: Full-time
Experience: Senior

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SENIOR/TALENT ACQUISITION SPECIALIST

Location: San Mateo, CA

In this highly visible role, the Recruiter will contribute to the development and execution of a best-in-class recruitment strategy and practices. He or she will also be a key member of the culture engine, supporting our new office and team in the San Mateo, CA, community engagement initiatives, and supporting corporate development plans. The Recruiter will contribute to the objectives that will provide an employee-oriented, high-performance culture that emphasizes empowerment, quality, productivity, goal attainment, and the recruitment and ongoing development of an outstanding workforce.

Key Duties and Responsibilities

  • People Operations representative and Culture Champion in our new office in the San Francisco Bay Area
  • Find and engage with top talent through advertisements, industry events, applicant review, and other sourcing methods
  • Support the talent acquisition process including candidate communication, reporting, requisitions, job boards, and more
  • Screen candidates against technical expertise and company values
  • Assist with the development and administration of programs, procedures, and guidelines to help align the workforce with the strategic goals of the company
  • In an effort to attract the best talent, build relationships with academic institutions, local biotech community, organizations, and networks
  • Responsible of all aspects of on-site candidate interviews, including scheduling, preparing all necessary documents, and providing a great candidate experience
  • Manage job advertisement platforms, ensuring high visibility of our career opportunities, top quality adverts, and promoting our company’s brand
  • Maintain recruitment applicant tracking system ensuring data accuracy
  • Deliver a seamless and positive experience for all candidates
  • Support the on-boarding process
  • Aspyrian Therapeutics is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties.

Desired Education, Skills and Experience

  • Bachelor’s degree required
  • 2+ years of recruiting experience in a life science company/staffing firm
  • Thorough understanding of the current talent landscape, trends and analytics
  • Passionate about process improvement and outstanding customer service
  • Strong interpersonal and communication skills are non-negotiable
  • Ability to exercise tact and discretion
  • Outstanding organizational skills, follow-up, and attention to detail
  • Ability to execute multiple tasks simultaneously and cut through ambiguity
  • Flexible and resilient to adapt to multiple demands and shifting priorities
  • Ability to work independently and with a team in a fast-paced environment
  • Unrivalled attention to detail and consistent delivery of the highest quality of work
  • Exceptional problem solving and time management skills
  • Self-motivated and proud of your work

 

Location: San Mateo, CA
Department: People Operations
Type: Full-time
Min. Experience: Some Experience

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TALENT ACQUISITION COORDINATOR

Location: San Diego, CA

In this highly visible role, the Talent Acquisition Coordinator will ensure that best practices are in place to provide an innovative best-in-class candidate experience and quality support to our People Operations team. This person will also be a key member of the culture engine, supporting office events, community engagement initiatives, and supporting corporate development plans. The Talent Acquisition Coordinator will contribute to the objectives that will provide an employee-oriented, high-performance culture that emphasizes empowerment, quality, productivity, goal attainment, and the recruitment and ongoing development of an outstanding workforce.

Key Duties and Responsibilities

  • Execute the company’s overall recruitment strategy
  • Assist with the development and administration of programs, procedures, and guidelines to help align the workforce with the strategic goals of the company.
  • Assist with employee orientation, development, training logistics, and recordkeeping.
  • Support the talent acquisition process including candidate communication, reporting, job descriptions, job boards, and more.
  • Responsible of all aspects of on-site candidate interviews, including scheduling, preparing all necessary documents, and providing a great candidate experience while on-site.
  • Manage all job advertisement platforms, ensuring high visibility of our career opportunities, top quality adverts, and promoting our company’s brand.
  • Maintain recruitment applicant tracking system ensuring data accuracy
  • Deliver a seamless and positive experience for all candidates
  • In an effort to attract the best talent, build relationships with academic institutions, local biotech community, organizations, and networks.
  • Support the on-boarding process
  • Other duties as assigned

Desired Education, Skills and Experience

  • Bachelor’s degree required
  • 2+ years of experience in recruitment coordination, project coordination or corporate administration
  • Flexible and resilient to adapt to multiple demands and shifting priorities
  • Ability to work independently and with a team in a fast-paced environment
  • Outstanding organizational skills, follow-up, and attention to detail
  • Self-motivated and proud of your work
  • Genuine interest in a career in People Operations
  • Exceptional problem solving, time management, and organizational skills
  • Passionate about process improvements and outstanding customer service
  • Excellent written and verbal communication skills
  • Ability to exercise tact, discretion and the initiative to efficiently meet the demands of multiple internal customers
  • Ability to work independently, execute multiple tasks simultaneously, and cut through ambiguity
  • Unrivalled attention to detail and consistent delivery of the highest quality of work
  • Strong interpersonal skills a must

Location: San Diego, California
Department: People Operations
Type: Full-time
Min. Experience: Entry

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SENIOR MANAGER QUALITY ASSURANCE – GMP

Location: San Mateo, CA

This position will provide and be directly responsible for a full range of Quality Assurance functions. The range of functions will support programs spanning development through late stage clinical and product commercialization. This will be primarily a GMP Product Quality role supporting the CMC and Supply Chain Teams. The position reports to the Director of QA (GMP and Validation) and directly supports the execution of Rakuten Aspyrian product and program objectives, requiring individual, team and department work contribution.

Key Duties and Responsibilities

  • Interface with Rakuten Aspyrian Analytical Development, Technical Operations, Regulatory Affairs, Supply Chain, Clinical Operations and other disciplines in support of Rakuten Aspyrian goals and initiatives
  • QA management of Contract Manufacturing Organizations (CMO)

o Master Batch Record Reviews and Executed Batch Record Reviews and Approvals; quality issue resolution, and batch disposition

o Ensure product meets all in process and release tests

o Ensure components, raw materials, starting materials, and third-party testing facilities are fit for the intended function

o Assess out of specification results and deviations, and resolve any issues to allow closure and the timely implementation of corrective actions (escalate as necessary)

o Ensure product is stored and transported at appropriate temperature conditions and per validated or qualified shipper

o Review any shipping excursions and ensure deviations are generated and material quarantined appropriately in the event of an excursion or other quality issue

o Responsible in full for adherence with the quality agreement provisions

o Ensure GMP compliance profile is maintained

o As required, review stability protocols, data and reports, and comply with annual stability commitments

o Ensure products meet established expiry dating

o Manage sample retention program and periodic re􀘜inspection activities and reporting as required

o Provide Quality input for process and method monitoring and annual product quality reports

o Support material review board meetings

o Interface with CMO on quality discipline activities and other matters

o Interface with CMO on regulatory inspections

  • Review Vendor and Rakuten Aspyrian Quality System documentation such as deviations, NCMRs, OOS’, Investigations, CAPAs and effectiveness checks
  • Prepare documentation for Material Review Board presentation and meetings
  • Perform assessments of raw material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements
  • Review Stability data and work with Analytical Development and Regulatory Affairs to justify, document and assign expiration dates for clinical material
  • QA Review and/ or approval of protocols and reports from vendors and Rakuten Aspyrian’s Research and Development, Technical Operations, and Analytical Development functions
  • Perform vendor qualification risk assessments
  • Vendor site visits and vendor audits
  • Write audit reports, and follow up on observation close-outs
  • Provide QA support for specification development and other analytical support as needed
  • Provide slides and metrics to support Quality Management Review meetings
  • Review chemistry, manufacturing and controls sections and summary sections of world-wide regulatory filings, amendments, supplements, annual reports and other submissions as needed
  • Review and/ or generate Quality Agreements
  • Clinical Operations Support:

o Review and approve packaging and labelling master and production batch records

o Provide input into clinical labelling content based upon the regulations governing region of distribution.

o Approve labels as required

o Review/assess temperature excursions

o Other clinical operation compliance activities as required

  • Develop/revise/implement/adhere to departmental policies and procedures affecting Quality Assurance
  • Assist with maintaining file organization within the Quality Department
  • Remain in compliance with Training program
  • Other duties as assigned

Desired Education, Skills and Experience

  • Associate Degree or higher
  • 10+ years of direct Quality Experience with increasing responsibilities and GMP knowledge
  • Excellent organizational skills and ability to meet deadlines
  • Exceptional self-management ability
  • Up to 25 % of travel including international travel required

Location: San Mateo, CA
Department: Quality
Type: Full-time: Full Time
Experience: Some Experience

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PRODUCT QUALITY ENGINEER

Location: San Mateo, CA

The Quality Engineer (QE) will have responsibility for field product quality and will provide support to the Rakuten Aspyrian Supply Chain Team, Clinical Operations and field personnel in the areas of product assurance and reliability. The QE will coordinate activities with outside vendors, manufacturing sites, distribution centres and field personnel in the performance of failure analysis of components used in implantable grade medical devices including needles, obturators, fibre optics and packaging/labelling of laser light systems and ancillary products.

The QE will provide input on supplier issues and recommend changes for improvements to operating efficiency. The QE will provide support in areas of product quality engineering to drive continuous improvements and work with supply chain team members to ensure highest product quality and assure compliance to internal procedures and applicable external standards and regulations. As a key member of the quality team, the QE will participate in the Rakuten Aspyrian Quality Management System (QMS) to support the manufacture and distribution of medical combination drug/devices and for expanding the system as products progress through development to commercialization. This individual will also be responsible for processing and trending of field quality complaints for clinical and marketed combination devices. The individual will also have a key role in working with outside vendors and participating in GxP quality audits and maintaining quality documents between Rakuten Aspyrian and vendors.

This position is a key member of the Rakuten Aspyrian Quality team. The individual will participate in the logistical planning of quality support for therapeutic laser devices, concomitant drug product and ancillary products. The position will participate in the oversight and maintenance of all controlled documents, procedures, reports, files, training records and scanned files.

Key Duties and Responsibilities

  • Develops, modifies, applies and maintains quality standards and specifications for processing materials into partially finished or finished materials product.
  • Devises and implements methods and procedures for inspecting, testing and evaluating product components, materials, packaging or processing methods.
  • Conducts quality assurance analysis of tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • Supports implementing containment and mitigation actions while driving timely disposition of non-conforming product
  • Conducts root-cause analysis using defined methodologies including identifying appropriate corrective and preventive actions and establishing effectiveness plans.
  • Supports production and process change control through review and approval of documentation, ensuring adequacy of verification or validation to support the change, good documentation practices and compliance to procedures.
  • Generates, reviews and approves quality system documents including manufacturing process updates, non-conformance related documentation, process and equipment qualifications, and change orders
  • Supports vendor assessment of methods or equipment for impact on manufacturing processes, product, and compliance to requirements.
  • Reviews and analyses quality trends with the Supply Chain team and recommends actions for process, equipment and system improvement
  • Coordinates with customer facilities and internal engineering resources to respond to customer facility questions and resolve complaints.
  • Participates in audit/assessment of manufacturing operations and recommends corrective/preventive actions and process improvements.
  • Communicates significant issues or developments identified during quality activities and participates in process improvements to instil rigor in processes and product.
  • Facilitating GxP documentation approval between Rakuten Aspyrian and outside vendors as well as internal customers to include assistance with MSAs, NDAs and Technical Quality Agreements
  • Participate in the change control process and/or assist with the review of documents to include product history files and batch records
  • Participating in the vendor qualification and oversight program in support of product Supply Chain needs
  • Provide product or vendor performance data for Management Review and work with various departments to draft appropriate metrics reports
  • Reviewing and approving documents from vendors against internal source documents, including batch records, specifications, stability information, and analytical methods/qualifications

Desired Education, Skills and Experience

  • Bachelor’s degree in manufacturing engineering, Mechanical or Electrical Engineering or similar branch of education preferred
  • CQE or Six-Sigma certification preferred
  • Minimum 5 years of experience in quality control of medical devices, IVDs or combination products
  • Excellent organizational skills and ability to meet deadlines
  • Ability to travel for purposes of training and vendor management
  • Collaborative and interpersonal skills to work in a team environment both internally and with outside vendors or clients
  • Ability to work in a fast-paced, rapidly changing environment
  • Working knowledge with Word, Excel, Adobe and formatting documents.
  • Experience with Electronic Quality/Document Management Systems required

Location: San Mateo, CA
Department: Quality
Type: Full-time: Full Time
Experience: Some Experience

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FIELD CLINICAL TRAINER – EUROPE

Location: EU Western Europe

The Field Clinical Trainers will be key members of the Clinical Operations team with responsibilities to train physicians and support staff to properly perform Aspyrian drug product infusions and photoimmunotherapy (PIT) procedures.The Field Clinical Trainer will also provide feedback to clinical and R&D regarding product performance. The Field Clinical Trainer may train site personnel with study-related data collection and/or documentation practices.

The ideal candidate will have a RN, PA, NP or other relevant clinical license with experience in surgical, interventional radiology, intensive care or radiation oncology settings, and with prior experience in an educator or trainer capacity.Additionally, a working knowledge of drug development process, GCP, ICH guidelines and EMA regulations is highly desirable.

The Field Clinical Trainer may be located anywhere in Europe within a reasonable distance of a major airport, and will report to the Associate Medical Director. This position will require the ability and willingness to travel extensively up to 70% time, within Europe as clinical study enrollment and caseload activities dictate.

Key Duties and Responsibilities

  • Educate, inform and observe doctors in the proper application of the Rakuten Aspyrian photoimmunotherapy treatment in patients
  • Provide training to physicians and support staff on proper drug product storage, handling, preparation, and infusion procedure following protocol design
  • Educate and inform doctors, nurses, and appropriate staff personnel of the proper use and maintenance of Rakuten Aspyrian products
  • Assessment and monitoring of physicians’ skill levels with Aspyrian products.Identify and perform retraining, as applicable or requested
  • Preparation of training materials (e.g., presentation slides, reference guides)
  • Provide clinical and technical feedback regarding device performance, user ergonomics and suggest design improvements.Similarly, identify improvements in procedure techniques that can reduce time and/or improve ease of use
  • Become the go-to expert in the company on study product infusion and PIT procedures
  • Assist and support Clinical Operations in ensuring protocol compliance
  • Assist and support site personnel with study-related data collection or documentation practices
  • Rakuten Aspyrian is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. This is an expectation of every employee and it allows for future growth opportunities.
  • Other duties as assigned

Desired Education, Skills and Experience

  • RN, PA, NP or other relevant clinical certification, with active license (as appropriate) preferred
  • Surgical, Intensive Care, Interventional Radiology, Emergency Room and/or Oncology experience desired
  • BSN, BS in Biomedical Engineering or Health Sciences degree desired
  • Minimum 3-5 years related pharmaceutical industry experience
  • Prior demonstrated experience in an educator/trainer capacity
  • Strong medical and anatomic knowledge
  • Ability to work independently
  • Excellent oral and written communication skills
  • Excellent interpersonal and team building skills
  • Able to quickly build rapport, credibility, and trust with physicians and operating room, radiology and infusion center staff
  • Ability to process and prioritize sensitive complex information and problem solve with good judgment under time constrains
  • Decisive, able to give procedural coaching/direction calmly and assertively
  • Understanding of regulatory guidelines for adverse event reporting for serious/unexpected events
  • Understanding of guidelines for reporting device malfunctions
  • Working knowledge of Federal Guidelines, Good Clinical Practices, drug development process, and conduct of clinical studies

Physical demands:

  • Must be able to lift up to 50 pounds on occasion
  • Must be willing and able to travel up to 70% of the time

Location: Western Europe, Western Europe
Department: Clinical
Type: Full-time
Min. Experience: Some Experience

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MEDICAL SCIENCE LIAISON

Location: EU Japan Regional, USA

The Medical Science Liaison (MSL) is an externally facing medical expert representing the Rakuten Aspyrian Medical Affairs organization. He/she is responsible for developing and maintaining professional relationships and engaging in the exchange of medical and scientific data with external customers (e.g. healthcare professionals (HCPs), investigators, key opinion leaders (KOLs), professional organizations etc) as appropriate and gathering/sharing insights. The MSL will collaborate with internal customers throughout the organization on the medical and scientific information relating to marketed products and products in development. This position will involve travel of more than 70%.

Key Duties and Responsibilities

  • Identify, establish and maintain ongoing long-term collaborative peer-to-peer relationships with KOLs and investigators
  • Provide medical education to external customers through the delivery of high-caliber presentations in a variety of settings and obtain valuable insights that can disseminated throughout the organization
  • Liaise regularly with internal colleagues to share field insights and feedback from external customers
  • Represent Medical Affairs and the company at medical conferences and meetings, advisory boards, outreach meetings etc. (including medical booth coverage)
  • Support medical expert engagement and congress/conference planning including but not limited to scheduling, review, assessment and write up of presentations/abstracts/posters
  • Serves as a field medical resource and accurately respond to medical inquiries in accordance with company policies, and applicable laws, regulations and ethical standards
  • Conduct regular reviews of journals etc. to stay current on the disease areas and products of interest to the company and maintain clinical, scientific, and technical expertise in oncology (present learning to internal colleagues)
  • Facilitate the handling of investigator-initiated trials and collaborative research inquiries
  • Provide field-based medical support to company's clinical trials as needed
  • Gather and disseminate competitive intelligence from multiple sources in accordance with company’s policies
  • Provide support for content development and delivery of clinical presentations
  • Provide support for content development of FAQs and medical inquiry responses
  • Other duties as assigned

Desired Education, Skills and Experience

  • Advanced degree in medical science (PhD, PharmD, NP, RN or MD) required
  • Minimum of 3 years’ experience as a MSL
  • Prior working experience in oncology (>1 year)
  • A well-established KOL oncology network is strongly preferred
  • Ability to build credible scientific relationships with KOLs and investigators
  • Ability to readily interpret, understand and present scientific or clinical data
  • Think strategically; apply knowledge and analytical skills in a highly regulated environment; and align medical and commercial strategies
  • Ability to summarize complex information and present in a clear, concise, and scientifically accurate manner to a range of audiences
  • Strong and effective communication (verbal and written) and presentation skills
  • Excellent ability in searching and interpreting medical literature
  • Competent in word, excel and other field-based electronic and communication tools to successfully fulfill the job
  • Strong understanding of industry and regulatory guidelines pertinent to appropriately interaction with healthcare professionals and other customers in a compliance manner and any relevant guidance's related to the MSL function
  • Estimated travel ~70%

Location: Regional USA, Europe, Japan
Department: Medical Affairs
Type: Full-time
Min. Experience: Some Experience

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DIRECTOR MEDICAL SCIENCE LIAISONS

Location: San Mateo, CA

The Director, Medical Science Liaisons (MSLs) is accountable for implementing and actively managing the Rakuten Aspyrian MSL team. He/she is responsible for establishing and maintaining professional relationships with the thought leaders, external healthcare customers and key internal colleagues to communicate scientific and clinical information. The candidate will create and maintain business processes and lead key strategic, cross-functional projects.

Key Duties and Responsibilities

  • Recruit, hire and retain a qualified, high-functioning MSL team
  • Directly supervise and manage the MSL team by encouraging MSL development and well as managing individual and team performance
  • Define the strategic direction for the MSL team and ensures alignment with medical affairs and corporate initiatives
  • Support MSL team with the identification and maintenance of relations with national and regional and medical and scientific key opinion leaders (KOLs)
  • Oversee and ensure the highest scientific standard and expertise across the MSL team to establish strong peer-to-peer collaborations and professional relationships
  • Support the team in engaging in scientific exchange and education about current and emerging therapies in a compliant fashion
  • Provide medical presentations to both internal and external audiences within legal, compliance and regulatory guidelines
  • Provide ongoing field updates and insights including competitive intelligence to internal stakeholders
  • Assist the team in partnering with Medical Affairs colleagues to deliver accurate medical and scientific information `
  • Work with Medical Affairs colleagues as appropriate on activities that may include advisory boards, speaker training, and development of scientific slides for topics of interest
  • Create, execute and maintain of SOPs and guidances for the MSL function
  • Develop MSL appropriate metrics to assess and track the success of the MSL team and function
  • Manage overall MSL budget and the administrative aspects of the team (e.g. approval of expense reports, database entries)
  • Provide appropriate mentoring and coaching to direct reports with respect to technical skills, business acumen/planning, and effective regional management
  • Develop and maintain scientific, clinical and therapeutic expertise in the disease states of interest
  • Work with cross-functional internal stakeholders to prepare the marketplace for products in development
  • Other duties as assigned

Desired Education, Skills and Experience

  • Doctoral degree (PhD, PharmD, or MD) required
  • Minimum of 7 years’ experience as a MSL with 3+ years’ experience managing a MSL group (full MSL function and/or regional or disease teams)
  • Four + years prior working experience in oncology
  • A well-established KOL oncology network is strongly preferred
  • Proven track record of success, especially in the areas of establishing and maintaining thought leader relationships, territory planning, and integration with other field roles
  • Demonstrated ability to comprehend complex scientific, medical, and emergent business issues and modify regional commercial meetings accordingly
  • Successful record of managing large and complex projects with minimal oversight
  • Strong interpersonal and communication skills, both oral and written
  • Excellent ability in searching and interpreting medical literature
  • Strong understanding of industry and regulatory guidelines pertinent to appropriately interaction with healthcare professionals and other customers in a compliance manner
  • Estimated travel ~40%

Location: San Mateo, California
Department: Medical Affairs
Type: Full-time
Min. Experience: Director

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SENIOR BIOSTATISTICIAN

Location: San Mateo, CA

The Sr. Biostatistician will provide statistical support for all phases of clinical development. Specific responsibilities include writing and reviewing statistical section of protocols, writing and reviewing statistical analysis plans, developing table, listing and figures shells, providing input to clinical development plans, and developing SAS programs.

Key Duties and Responsibilities

As a Senior Biostatistician, you will work closely with colleagues (Medical, Clinical Scientists, Statistical Programming, Data Management, Clinical Operations, Project Management, Medical Writing, Safety and Regulatory) as well as external CRO partners to:

  • Oversee CROs, vendors, and consultants for the statistical deliverables, while ensuring consistency of approach for all studies assigned to CROs; review their adherence to timelines, as well as quality and cost.
  • Consult in the design and development of clinical trials to ensure compliance with regulatory requirements, sponsor and CRO SOPs and working practice documents.
  • Review study and project related documents that require statistical input, including the protocol, CRF and database design, SAP, SPP (statistical programming plan), and 3rd party data transfer specifications.
  • Provide sample size calculations and generate randomization schedules as applied.
  • Provide input into development of case report forms (CRFs).
  • Develop and/or review statistical analysis plans, including the development tables, listings and figures (TFLs) shells.
  • Review/validate SDTM and ADaM, ensure that CDISC compliance.
  • Generate analysis datasets and TFLs to support the analysis of study data using SAS.
  • Provide statistical (programming) support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Prepare statistical sections of clinical study reports.
  • Participate in standardization efforts.
  • Maintain effective and efficient communication both within the Biostatistician and Statistical Programming group and with the other functional groups.
  • Contribute to or develop Biostatistics and quality standards, SOPs and WPs.
  • Solve problems proactively and determine when and how to escalate issues.
  • Keep manager informed of progress and any issues that may impact process compliance, data integrity, reporting accuracy, long term efficiency, timelines, or quality.
  • Perform other functions as necessary or assigned.

Desired Education, Experience, Skills

  • MS or PhD degree in Statistics and a minimum of 5 years of relevant industry experience. PhD’s degree preferred.
  • Experience with oncology clinical trials strongly preferred.
  • Experience in BLA/NDA Submission and/or interactions with the regulatory requests is strongly preferred.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.
  • Experience with SAS.
  • Knowledge of industry standards, such as the FDA guidelines, ICH guidelines and CDISC data structures.Experience with working with CRO’s, vendors, or consultants preferred.
  • Must have demonstrated ability to support multiple difficult assignments with challenging timelines.
  • Must have excellent verbal and written communication skills.
  • The qualified applicant must be flexible, well-organized, and can work well under pressure and prioritize.

Location: San Mateo, California
Department: Biostatistics
Type: Full-time
Min. Experience: Senior Level

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SENIOR SPECIALIST- ANALYTICAL FORMULATION DEVELOPMENT

Location: San Diego, CA

The Sr. Specialist is a key member of the Analytical Formulation Development team and is responsible forsupporting Aspyrian’s late-stage clinical program of a first-in-class photoactivatable monoclonal antibody conjugate. The ideal candidate will have shown proficiency in advanced analytical characterization techniques for antibody-drug conjugates and the ability to collaborate with CROs and other third party testing organizations. Responsibilities include method development and validation, structure elucidation, structure/function assessment, and analytical support of conjugation, formulation and development stability studies.

Key Duties and Responsibilities

  • Manage and support late-stage method validation at CRO/CMOs for testing of in-process materials, drug substance, drug product, and stability
  • Lead in proposing and implementing effective analytical control strategies, product specifications and identifying critical quality attributes related to drug substance and drug product manufacturing
  • Provide an in-depth technical assessment on drug substance and drug product In-Process Control strategy and reduce compliance risk
  • Lead OOS, OOT and investigations at drug substance and drug product analytical QC labs
  • Create and review technical documents including analytical method development reports, qualification and validation protocols and reports, and standard operating procedures in compliance with FDA, EMA and PMDA regulatory requirements
  • The candidate needs to be familiar with ICH, FDA and USP guidances
  • Support late-stage process development, process validation and FMEA
  • Perform analytical characterization test methods suitable to support in-process, drug substance and drug product testing that meets anticipated regulatory requirements for Aspyrian’s lead clinical candidate
  • Provide analytical support for drug product formulation and conjugation process development activities
  • Support development and qualification of state-of-the-art analytical methods for product quality and stability assessments
  • Summarize, interpret, and critically evaluate analytical data. Present results at group/team meetings
  • Maintenance and troubleshooting of laboratory equipment
  • Applicant should be an effective communicator of ideas and results to the team and should have the ability to proactively identify issues and suggest solutions in a collaborative multidisciplinary environment
  • Rakuten Aspyrian is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. As a key member of the Analytical Formulations Development team, the Sr. Specialist is expected to participate in operational and strategic discussions with the Technical Operations group
  • Other duties as assigned

Desired Education, Skills and Experience

  • Minimum of 8-10 years of relevant industry experience in analytical development with biologics
  • M.S. or PhD in a life or physical science
  • Knowledge and hands-on experience with physicochemical characterization techniques (including but not limited to): HPLC (SEC, IEX, RP), mass spectrometry (intact mass and peptide mapping), capillary electrophoresis (icIEF, CE-SDS), and cell-based potency assays
  • Experience with formulation development is a plus
  • Excellent oral and written communication skills. The position will require preparation of written reports in support of development and/or regulatory filings such as IND amendments and BLA
  • Excellent interpersonal and team building skills
  • Ability to work independently, analyse and work with attention to detail, process and prioritize sensitive complex information and problem solve
  • Ability and willingness to travel at times up to 10% nationally and internationally, depending on Technical Operation activities

Location: San Diego, California
Department: TechOps
Type: Full-time
Min. Experience: Senior Level

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SENIOR STATISTICAL PROGRAMMER

Location: San Mateo, CA

The Senior Statistical Programmer is responsible for providing timely support to clinical study teams on all programming matters (simple to complex) related to processing data from clinical studies. You will play a key role in developing, implementing, and evaluating statistical programming standards and processes. This role will function as the lead programmer on assigned studies, phase I to IV. The Senior Statistical Programmer will create, document, and validate corresponding related SAS programs, datasets, and outputs needed for the analysis, interpretation, and monitoring of clinical trials. You will also hold responsibilities for maintenance and management of the departmental program codes, documentations, and output as they are developed. The Senior Statistical Programmer will respond to both planned and ad-hoc data requests from the clinical team. You will participate actively in project teams. The Senior Statistical Programmer will interact with both internal parties and external study vendors, acting as a representative of Clinical Programming.

Key Duties and Responsibilities

As the Senior Statistical Programmer, you will work closely with colleagues (Medical, Clinical Scientists, Statisticians, Project Management, Medical Writing, Safety, Clinical Operations, Regulatory, and Data Management teams) as well as external CRO partners to:

  • Oversee CROs, vendors, and consultants for the statistical programming deliverables, while ensuring consistency of approach for all studies assigned to CROs; review their adherence to timelines, as well as quality and cost.
  • Consult in the design and development of clinical trials to ensure compliance with regulatory requirements, sponsor and CRO SOPs and working practice documents.
  • Review study and project related documents that require statistical programming input, including the protocol, CRF and database design, SAP, SPP (statistical programming plan), and 3rd party data transfer specifications.
  • Responsible for the generation of study deliverables and being the Clinical Programming point of contact for other functions.
  • Retrieve clinical data and metadata from EDC systems and create SAS datasets; create SAS datasets from other systems data as well (IWRs, Labs, Imaging, etc.).
  • Develop, validate, and document programs, SAS Macros, and systems used.
  • Program TLFs needed for analyses and reporting, including for CSRs, DSURs, IB, DSMBs, etc.
  • Fulfill ad-hoc requests in support of data collection/cleaning/data presentations/ or analyses.
  • Review CDISC specifications and output for SDTM and ADaM datasets as well as define.xml, reviewers guide documents and Pinnacle 21 validation reports for a clinical study. Create ADaM specifications when needed.
  • Review and provide feedback on the output SAS datasets from the database to ensure that the clinical database and the data collected are complete and, in a format, conducive to efficient and error-free SAS programming.
  • Keep abreast of biopharmaceutical trends and best practices in the use of SAS as well as discuss technical and software concepts with the clinical group.
  • Participate in standardization efforts.
  • Maintain effective and efficient communication both within the Clinical Programming group and Biometrics, as well as with the other functional groups.
  • Contribute to or develop programming and quality standards, SOPs and WPs.
  • Present to internal audiences on study-specific issues and processes.
  • Solve problems proactively and determine when and how to escalate issues.
  • Keep manager informed of progress and any issues that may impact process compliance, data integrity, reporting accuracy, long term efficiency, timelines, or quality.
  • Perform other functions as necessary or assigned.

Desired Education, Skills and Experience

  • Bachelor’s degree in a scientific discipline, Mathematics, Statistics or Computer Science Experience required. Master’s degree preferred.
  • A minimum of 5 years of SAS programming experience required.
  • A minimum of 2 years of clinical trials experience required.
  • Experience with oncology clinical trials preferred.
  • Experience in BLA/NDA Submission and/or interactions with the regulatory requests is preferred.
  • Must be familiar with FDA and ICH guidance and regulations as they relate to statistical programming, 21CFR Part 11, E9, good programming practices and software validationmethods.
  • Experience with working with CRO’s, vendors, or consultants preferred.
  • Must have advanced experience with SAS Base.
  • Must be proficient in SAS MACRO language, ODS.
  • Experience with SAS/STAT, SAS/Graph required.
  • Experience with SAS JMP and/or SAS JMP Clinical preferred.
  • Experience with CDISC STDM and ADaM required.
  • Experience performing a leadership role in project teams preferred.
  • Must have demonstrated ability to support multiple difficult assignments with challenging timelines.
  • Must have excellent verbal and written communication skills.

Location: San Mateo, California
Department: Biostatistics
Type: Full-time
Min. Experience: Senior Level

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DIRECTOR OF REGULATORY AFFAIRS

Location: San Mateo, CA

The Director of Regulatory Affairs will be responsible for working with Rakuten Aspyrian development teams to implement global regulatory affairs strategy for assigned company projects with the goal of ensuring timely clinical study execution, CMC development, and BLA readiness for our biologic/drug combination therapies. Responsibilities will span pre-IND through post-approval phases of development. This individual will interact with regulatory health authorities in all countries where Rakuten Aspyrian conducts clinical studies and/or intends to market a product. The Regulatory Affairs Director will work closely with other functions of the company, including quality assurance, clinical affairs, clinical development, pharmacovigilance, medical affairs, CMC, regulatory operations, and project management.

Key Duties and Responsibilities

  • Ensure that corporate policies and clinical programs are aligned with rules and regulations governing the global development of pharmaceuticals
  • Develop and implement strategies for the earliest possible approval of regulatory applications
  • Advise and manage regulatory consultants
  • Oversee ongoing projects from a Regulatory perspective.
  • Participate in product strategy teams to provide advice and direction, including identifying and assessing regulatory risks regarding global regulatory requirements and strategies
  • Work closely with development teams to write, review, and revise documents for submission to regulatory health authorities (US, EU, Asia, Canada) to ensure:
    • Appropriate planning, review, and tracking of all regulatory submission documents
    • Acceptability of data, procedures, and other documentation presented in support of clinical trials through submission of marketing application(s)
    • Regulatory arguments are presented clearly and conclusions are supported by data and their associated risk assessments
    • Appropriate reporting of safety
    • Document publishing, QC, and submission occurs in a timely fashion
  • Interact and communicate with regulatory health authorities in countries where Rakuten Aspyrian is conducting clinical trials or plans to market product
  • Perform regulatory intelligence activities to keep current on the global regulatory environment and competitive products; communicate such environment to the teams
  • Participate in the development of Regulatory Affairs department SOPs
  • Work with regulatory and quality teams to ensure compliance with the global regulatory health authority regulations and interpretations and to design and implement training on regulatory issues for staff and for business stakeholders
  • Other duties as assigned

Desired Education, Skills and Experience

  • Bachelor’s and Master’s or Ph.D. degree in scientific, healthcare, or related field or equivalent.
  • A minimum of 7 years of pharmaceutical industry experience
  • 5+ years of regulatory experience
  • Experience in a strategic leadership capacity
  • Must demonstrate an understanding of drug development and knowledge of FDA requirements
  • Direct experience with FDA required and international experience preferred
  • Device and/or combination product experience preferred
  • Highly organized with attention to detail.
  • Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills
  • Working knowledge of electronic publishing/file management system.
  • Familiarity with MS Word, MS Excel, Adobe Acrobat and PowerPoint applications.
  • Exceptional self-management ability
  • Travel as needed for interactions with Regulatory Health Authorities

Location: San Diego or San Mateo, California
Department: Regulatory
Type: Full-time
Min. Experience: Senior Level

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CLINICAL MEDICAL DIRECTOR – EUROPE

Location: Western Europe

Rakuten Aspyrian is building its clinical team to support its ongoing and upcoming clinical studies, including a global Phase 3 clinical study. The Senior Medical Director, Medical Director or Associate Medical Director will be a key member of the clinical team with responsibilities to support Rakuten Aspyrian’s current clinical development program, provide medical expertise to company and project team members, participate as a project team member in new product development and be the medical lead in Phase 1 and Phase 2 trials commensurate with their experience.

The ideal candidate will have an MD, DO, or equivalent degree, hold an active MD &/or DO license, with experience in medical, surgical, or radiation oncology preferred. Additionally, previous industry experience including a working knowledge of drug development process, GCP, ICH guidelines, FDA and EMA regulations as well as direct involvement as an investigator of clinical studies or direct experience in managing clinical operations, medical affairs, and medical safety and monitoring is highly desirable.

The Clinical Medical Director may be located anywhere in Western Europe within a reasonable distance of a major airport, and will report to the Chief Medical Officer.

Key Duties and Responsibilities

  • Instruct and oversee investigator’s proper performance of Rakuten Aspyrian therapies
  • Provide medical oversight of clinical trials to ensure company standard operating procedures, company directives and regulatory requirements are understood and followed
  • Provide medical expertise to identify new product opportunities and portfolio development
  • Active participation as a member of the clinical development team for early stage products
  • Medical lead for Phase 1 and Phase 2 clinical trials
  • Participate in clinical trial development, including providing input into and/or developing materials such as target product profiles, protocols/amendments and informed consents
  • Work with the Medical Safety and Pharmacovigilance team to perform clinical site medical monitoring as necessary
  • Perform medical review of clinical study reports
  • Attend and present at investigator and company meetings as needed in collaboration with Medical Affairs
  • Manage integration of clinical programs with regulatory strategy
  • Participate in clinical site identification, initiation oversight, and close-out
  • Support the clinical operations group in the management of the CRO’s timely execution of clinical studies
  • Actively participate in interactions with KOLS, in coordination with Medical Affairs
  • Other duties as assigned

Desired Education, Skills and Experience

  • An MD, DO, or equivalent degree with active medical license required
  • Oncology experience required, preferably in medical, surgical &/or radiation oncology
  • Expertise in clinical trial design in oncology preferred
  • Experience in Medical Affairs, Medical Safety, Medical Monitoring and Medical lead on Phase 1-2 clinical trials highly valued.
  • Working knowledge of FDA & EMA guidelines for adverse event reporting, Federal Guidelines, GCP, and ICH-GCP
  • Familiar with FDA & EMA guidelines for IND and NDA submissions
  • Understanding of clinical pharmacology with an emphasis on PK/PD of antibodies preferred
  • Working knowledge of biostatistics, data management, and clinical operations' procedures
  • Proficient in the drug development process
  • Strong analytical skills
  • Excellent oral and written communication skills
  • Outstanding interpersonal and team building skills
  • Ability to work independently, analyse, and work with attention to detail, process and prioritize sensitive complex information and problem solve
  • Ability to exercise creativity and judgment
  • Able to travel approximately 50% of the time (including overnight stays) by air, rail, or auto to clinical sites to support European clinical studies.

Location: Western Europe, Western Europe
Department: Clinical
Type: Full-time
Min. Experience: Senior Level

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CLINICAL SCIENTIST

Location: San Mateo, CA

The Clinical Scientist will be a key member of the Clinical team with responsibilities to provide scientific support for clinical development activities, including implementation of scientific clinical strategy into trial design and coordination of clinical development activities related with clinical pharmacology. This role will be integral in facilitating successful and timely initiation and completion of the company’s clinical development programs.

The Clinical Scientist will collaborate closely with Translational R&D, program management, clinical operations, biostatistics, data management, regulatory, and business development (life cycle management), as well as externally with Clinical Research Organizations, Clinical Sites, and Clinical Investigators. Additionally, the Clinical Scientist will support the development of scientific external relationships with key therapeutic opinion leaders (KOLs) and provide clinical input into safety and regulatory interactions.

Extensive knowledge and hands on experience supporting clinical sciences in Oncology including clinical trial design, endpoint selection, statistics, clinical pharmacology, implementation of correlative studies, companion diagnostics, biomarkers, and ADA/Nab evaluation is required. Knowledge of clinical safety, immuno-oncology and mechanism of action of anticancer therapies, including biologics is preferred. Strong knowledge of drug development process, GCP, ICH guidelines and FDA regulations is highly desirable. The Clinical Scientist will be a self-motivated, creative, detail oriented, hands-on individual with the ability to formulate, develop, and support clinical trials while operating in a highly dynamic environment.

Duties and Responsibilities:

  • Design clinical trials based on clinical data, regulatory guidelines, statistical analysis, company goals, reimbursement factors, commercial, and competitive landscape.
  • Develop, propose, assess, and present different clinical strategy options. Assess risk/benefits of variations of the strategy. Create clinical development plans for various oncology indications, working as part of an integrated drug development team.
  • Incorporate scientific input from the preclinical pharmacology team to guide the design of translational studies from Phase 1 to Phase 3.
  • Support the completion of clinical trial documents including clinical protocols, investigator brochures, DSURs, and clinical modules of the IND.
  • Provide input for the clinical database build, CRFs, monitoring plan, data management plan, and statistical analysis plan.
  • Manage CRO engagements with respect to clinical pharmacology.
  • Define biomarkers and/or clinical correlative studies that would support understanding and guide future development of the technology.
  • Perform ongoing review of clinical data including review of draft tables/listings/figures to support data cleaning, analysis, and interpretation of study results. Proactively define questions to be addressed in the clinical data, and either perform the analysis or engage with the appropriate experts to do so.
  • Provide scientific expertise to Clinical Operations and Biometrics by responding to questions or clarifying issues arising during study conduct.
  • Lead review of study data (i.e., Tables/Listings/Figures and bioanalytical data) and development of Clinical Study Reports; prepare data for clinical presentations and scientific publications including posters, abstracts, and manuscripts.
  • Develop and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors.
  • Prepare presentations, engage in discussions, record minutes and actions, and assess impact on the program plans through discussions with KOLs, advisory boards, consultant meetings and investigator meetings as part of life cycle management.
  • Create a database on the competitive landscape and provide insights on strategic development pathways.
  • Support the Business Development team providing clinical science expertise to evaluate and execute due diligence for the licensing or external assets or for the establishment of collaborations with other corporations.
  • Proactively seek out and recommend process improvements.
  • Anticipate potential study problems and prepare contingency plans as needed.
  • Participate in Development Planning for assigned compounds.
  • Aspyrian Therapeutics is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties.

Education and Experience:

  • Advanced degree in life sciences (MD, PhD or equivalent).
  • Minimum 5 years of experience supporting design, planning, executing, reporting and publishing of clinical studies.
  • Strong scientific background in oncology with deep understandings of current pharmacological mechanisms of oncology drugs including immuno-oncology.
  • Strong experience of clinical study design, including scientifically, medically and statistically appropriate endpoints.
  • Up to date in new clinical trial designs in oncology.
  • Robust understanding of clinical pharmacology to support PK, biomarkers, correlative studies and other studies integrate into clinical research protocols.
  • Extensive experience in analysis and interpretation of clinical data, including the use of software packages to analyze clinical data.
  • Understanding of the design and implementation of companion diagnostics for patient selection or to evaluate drug action.
  • Understanding of clinical biostatistics.
  • Comprehensive understanding of the drug development process in all phases of testing from Phase 1 to Phase 3 clinical studies.
  • Experience with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements
  • Strong analytical and strategic thinking skills.
  • Experience with interacting with clinical investigators and medical experts.
  • Excellent oral, written, and interpersonal communication skills (fluency in written and spoken English is required).
  • Ability and willingness to travel as needed.

Location: San Mateo, California
Department: Clinical Development
Type: Full-time
Min. Experience: Senior Level

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SENIOR CLINICAL TRIAL MANAGER

Location: San Mateo, CA

The Senior Clinical Trial Manager will be a key manager with responsibilities to manage various aspects of clinical trials from study start-up through database lock in coordination with clinical operations leadership. This is an excellent opportunity to join a rapidly growing company to advance novel cutting-edge anticancer therapies into registration trials and later commercialization.

The ideal candidate will have 7+ years of experience with site monitoring and study/ CRO vendor management with previous experience with oncology (head and neck cancer), combination drug-device studies, and/or global clinical trial experience. The candidate will have strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations.

Key Duties and Responsibilities

  • Manage operational aspects of clinical trials from study start-up through database lock asassigned, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements
  • Manage study-related vendors including CROs and contract labs
  • Serve as point of contact for study site staff and investigators
  • Provide input into study-related materials such as protocols/amendments, informed consent templates, monitoring plans, data management plans, eCRF & CRF forms/completion guidelines/source doc forms, lab manuals, and study-related forms and logs
  • Perform site visits (qualifications, initiations, routine monitoring visits, closeouts) and ensurevisit-related documents are generated
  • Review monitoring reports, protocol deviations and data listings to ensure reliable quality data is and has been delivered
  • Manage site payment processes
  • Facilitate site study drug and study supplies orders, and ensure site accountability records are Maintained
  • Participate in clinical operations department administration as assigned, for example:
  • - Establishing and managing timelines, costs, and quality metrics and ensuring they are met
  • - Establishing/reviewing department objectives, SOPs, and work practices

Desired Education, Skills and Experience

  • Bachelor’s degree or equivalent in the life sciences or related field
  • Minimum 7 years related industry experience including:
  • - Site monitoring
  • - Study and CRO/vendor management
  • ACRP CCRA certification a plus
  • Experience with global clinical studies
  • Previous experience with oncology (ideally head and neck cancer) and/or combination drug-device studies is preferred
  • Previous experience managing vendor contracts and budgets preferred
  • Strong organizational and project management skills, including ability to multitask andorganize/track information
  • Strong working knowledge of the drug development process, GCP, ICH guidelines, and FDAregulations
  • Proactive recognition of issues as they arise with resolution and/or appropriate escalation tomanagement as warranted
  • Excellent interpersonal, written, and verbal communication skills
  • Ability to work independently and in a team environment
  • Detail-oriented
  • Strong computer skills and high level of proficiency with Microsoft Office (e.g. Word, Excel,PowerPoint, Outlook) and Adobe Acrobat programs
  • Ability and willingness to travel at times up to 50% nationally and internationally, depending on trial activities

Location:  San Mateo, CA
Department: Clinical
Type: Full-time
Min. Experience: Senior Level

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VICE PRESIDENT, CLINICAL DEVELOPMENT

Location: San Mateo, CA

The VP of Clinical Development work under the supervision of the Chief Medical Officer. He or she will be a key leader supporting strategy and operational implementation of clinical activities to support development of Aspyrian's clinical assets. This position will involve extensive coordination with the Chief Medical Officer, external CROs and the Aspyrian's Clinical Operations Team, Medical Directors, Clinical Scientists, Biostatistics, Clinical Pharmacology, Regulatory Affairs and Quality Assurance. This position will form a tight alliance with Program Management at Aspyrian to integrate resources, to align operational activities between functions, to maximize efficiency, cut costs of execution and meet timelines.

Day-to-day responsibilities will include direct oversight of the clinical trial programs, with a focus on clinical operations, interactions with CROs and preparation of protocols or protocol amendments. The position will be a key participant of Development SubTeams, with subject matter experts from key functions, such as Translational Medicine, Regulatory Affairs, Medical Affairs, Biostatistics/Data Management, Pharmacovigilance, Quality Assurance, Business Development, and Commercial Operations. This individual will provide clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development.

The position will collaborate with the Chief Medical Officer, Business Development and the commercial team to develop a commercialization strategy which will include development of TPPs based on competitive assessment and target positioning, and will align the clinical development strategy with the commercial strategy.

The role may be based out of our San Mateo or San Diego, CA offices.

Key Duties and Responsibilities

  • Lead the expansion of internal clinical capacity and manage/lead the clinical team and clinical trial execution at Aspyrian to support current and future clinical trials from Phase 1 to NDA/BLA submissions.
  • Implement best practices and standards for trial management in collaboration with other members of the clinical operations team.
  • Develop and oversee clinical timelines, budget forecasts, budget tracking, and budget review. Will be accountable for achievement of trial timelines within budget.
  • Work in close collaboration and lead the clinical operations personnel, who will provide oversight of clinical trials regarding operational aspects.
  • Define the clinical actions, assign clinical resources, clinical budget, monitor project status, identify risks of clinical execution. Work with Program Management to assure deep integration of objectives, achievement of milestones according to the timelines, and optimal use of resources across functions.
  • Will work with Data Management, Pharmacovigilance, Medical Directors and Medical Affairs to coordinate real time availability of clinical trial data, assuring data integrity, including safety, efficacy, pharmacokinetic, and correlative studies data to provide consolidated information for trial progress.
  • Review statements of work, master service agreements, and quality agreements as relates to clinical programs.
  • Collaborate with the Pharmacovigilance and Medical Directors and be jointly responsible with the CMO, Pharmacovigilance, Medical Directors and Medical Affairs for the clinical safety, pharmacovigilance and medical monitoring activities of clinical trials and post-marketing responsibilities.
  • Ultimate responsibility for clinical development plans, clinical trial protocols, clinical pharmacology, data analyses, clinical study reports, and other related clinical documents.
  • Ensure with QA that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trials.
  • Will support and will be accountable for clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
  • Partner with the Clinical Teams, Translational Research, Medical Affairs, Regulatory, Pharmacovigilance, Data Management, Quality and Commercial teams to identify and address key questions related with clinical development.
  • Key Contributor to the medical/scientific input for multi-disciplinary team activities including SubTeams that are involved in life-cycle management and program prioritization.
  • Collaborate with Medical Affairs and Commercial Teams to develop a strong group of Key Opinion Leaders.
  • Development of publication plan and directly oversee timely clinical data communication.
  • Serve as a external spokesperson of the clinical programs in interactions with development partners, investigator meetings, and advisory boards.
  • Other duties as assigned.

Desired Education, Skills, and Experience

  • MD or PhD degree. Oncology board certification preferred.
  • At least 10 years of clinical development leadership experience in oncology within biopharmaceutical, companies, including drug and device clinical development. At least 5 years within a similar role as listed in this job description.
  • Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Experience in representing the sponsor in front of regulatory agencies
  • Demonstrate experience in clinical design and implementation of Phase 1 to Pivotal Clinical studies in oncology, with evidence direct leadership of trials that meet the timelines, budget, expected outcomes and lead to regulatory success of innovative medicines.
  • Direct experience in clinical development of biologics and small molecules.
  • Knowledge of statistical concepts as they relate to clinical plans.
  • Knowledge of clinical pharmacology.
  • Knowledge of adaptive trials and design of trial to support accelerated approval under accelerated and Restricted Approvals Under Subpart H and Subpart E.
  • Experience managing clinical CROs from RFP to statements of work to coordinating execution
  • Knowledge of the day-to-day medical monitoring of clinical trials (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports).
  • Knowledge in pharmacovigilance, including the receipt and processing of ADRs, completion of MedWatch forms, and generation of Periodic Safety Update Reports.
  • Strong communication and collaboration skills. Ideal candidate will have a network of external thought leaders within oncology, who serve as advisers.
  • Broad and updated understanding of the industry status and upcoming innovation in clinical and molecular oncology.
  • High emotional intelligence, sound temperament, and professional attitude.
  • Outstanding leadership and management capabilities to build, motivate and manage a strong operational organization.
  • Personal alignment with Aspyrian's values, mission and vision.
  • Broad business perspective to integrate clinical concepts as part of the overall corporate strategy.
  • Excellent organizational skills and ability to meet deadlines.
  • Ability to see the big picture and pay attention to details.
  • Hands-on, action oriented. Proactive in anticipating and addressing difficulties.
  • Willing to travel to support clinical and corporate activities.

Location: San Mateo, California
Department: Clinical Development
Type: Full-time
Min. Experience: Senior Executive

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CLINICAL QUALITY MANAGER

Location: San Mateo, CA

The Clinical Quality Manager will be responsible to manage various clinical quality related activities in coordination with clinical team leadership. The ideal candidate will have 7 + years of experience in clinical quality and process improvement. The candidate will have broad working knowledge of the drug development process. Global clinical trial quality experience is a plus.

Key Duties and Responsibilities

  • Ensure clinical processes are conducted in accordance with applicable regulations and guidances
  • QA and QC review of clinical documents, publication and presentation materials and clinical sections of regulatory submissions
  • Develops, performs and manages ongoing Clinical QA activities
  • Ensure maintenance and audit of clinical trial documents, both from CROs and internal, as appropriate, including Trial Master Files
  • Assist in identifying non-conformances during clinical trial conduct, provides risk mitigation strategies and feedback and recommendations to facilitate ongoing process improvement.
  • Management of CAPA plans and site audits as warranted
  • Assist in the writing and review of Clinical Quality-related SOPs
  • Participate in cross-functional meetings and act as the point person for clinical quality activities
  • Other duties as assigned

Desired Education, Skills, and Experience

  • Bachelor’s degree or equivalent in the life sciences or related field
  • Minimum 7 years related clinical quality experience in a similar environment
  • Develop and maintain GCP/ICH compliant processes
  • Demonstrated ability to work independently and with cross-functional teams, including Clinical, Medical,
  • Data Management, Quality, Regulatory and CMC
  • Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA/QC review of data, clinical and medical documents
  • Previous experience with oncology (head and neck cancer), combination drug-device studies, and/or global clinical trial experience is a plus
  • Strong organizational and project management skills, including ability to multitask and organize/track information
  • Willingness to travel, at times, up to 20-30%
  • Location: San Mateo, CA
  • Department: Clinical
  • Type: Full-time
  • Min. Experience: Manager

 

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VICE PRESIDENT OF GLOBAL REGULATORY AFFAIRS

Location: San Mateo, CA

The Vice President of Global Regulatory Affairs will be a key leader of our management team and will provide management and leadership of the Regulatory Affairs to support the development and implementation of regulatory strategies and processes to secure worldwide product approvals.

The VP of Global Regulatory Affairs will work directly with Rakuten Aspyrian’s functional leaders and external consultants and will lead the integration of Regulatory Affairs across all the operative functions related with clinical development, CMC, devices, quality assurance and future product commercial launch initiatives.

Desired areas of expertise include the following: (i) clinical trial design including trial design for accelerated approvals, (ii) pharmacovigilance and drug safety compliance, (iii) regulatory submissions and discussions with the FDA, EMA and PMDA, (iv) CMC/cGMP of biologics to support pivotal studies and commercial launch, (v) device regulatory compliance for world-wide use, (vi) requests for orphan designation, breakthrough designation, fast track, accelerated approval, (vii) commercial launch and product promotional activities.

Understanding of Quality Assurance and Quality Management Systems will be valued.

We are looking for a hands-on candidate with strong leadership kills, a candidate that thrives in a fast-paced, highly interactive, and non-bureaucratic start-up environment, a candidate with excellent interpersonal skills that is determined to execute under tight timelines, a candidate that is energized by our mission to provide the patients with transformative treatments so they can conquer their disease.

Desired areas of expertise include the following:

  • (i) clinical trial design including trial design for accelerated approvals
  • (ii) pharmacovigilance and drug safety compliance
  • (iii) regulatory submissions and discussions with the FDA, EMA and PMDA
  • (iv) CMC/cGMP of biologics to support pivotal studies and commercial launch
  • (v) device regulatory compliance for world-wide use
  • (vi) requests for orphan designation, breakthrough designation, fast track, accelerated approval
  • (vii) commercial launch and product promotional activities.

Understanding of Quality Assurance and Quality Management Systems will be valued and potentially the Regulatory Affairs head will be considered to oversee the Quality Assurance organization.

We are looking for a hands-on candidate with strong leadership kills, a candidate that thrives in a fast-paced, highly interactive, and non-bureaucratic start-up environment, a candidate with excellent interpersonal skills that is determined to execute under tight timelines, a candidate that is energized by our mission to provide the patients with transformative treatments so they can conquer their disease.

The Regulatory Affairs position will be based in Aspyrian’s San Diego corporate office, however, we may consider the flexibility to work remotely from the Bay Area as long as the candidate can visit frequently the San Diego corporate office. The Regulatory Affairs head will report directly to the President/CEO.

Key Duties and Responsibilities

  • Provide management and leadership of the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide
  • Serve as point of contact and represent the Company before regulatory authorities, including preparation of meeting agendas, materials, and minutes
  • Execute US /OUS regulatory project plans in collaboration with Rakuten Aspyrian management, clinical, CMC and device groups as well as regulatory consultants, and CROs
  • Manage and oversee of all operational aspects of regulatory submissions, including maintaining timelines and developing and coordinating submission content for various regulatory FDA, EMA and PDMA applications, safety, amendments, and IND safety and annual reports
  • Have and maintain awareness of existing and new regulations and guidance for quality, CMC, nonclinical and clinical matters, devices and advise on expectations and requirements for US and OUS compliance
  • Oversee Quality Management Operations
  • Provide counsel, training, and interpretation of FDA and other regulatory agencies to Company personnel
  • Contribute to Rakuten Aspyrian corporate infrastructure via development of SOPs, work instructions, etc.
  • Develop strategy and assure compliance of devices compliance with FDA regulations and the Medical Device Directive (MDD) in the EU and other equivalent regulatory requirements at other territories
  • Responsible for the review and approval of promotional, advertising, and labeling items
  • Other duties as assigned

Desired Education, Skills and Experience

  • Minimum of 10 years of regulatory experience in US/OUS (EU/Japan) related with pharmaceutical/device development and commercialization
  • Experience in oncology programs and accelerated approvals
  • B.S. / M.S. degree or higher in a life science field is minimum. Ph.D. or equivalent is highly desired. RAC accreditation is desirable
  • Experience in representing the sponsor and interfacing with the FDA, EMA and PDMA
  • Demonstration of successful submissions of INDs, NDAs, BLAs and/or PMAs; experience with drug-device combinations is desirable
  • Experienced in cGMP of biologics
  • Extensive knowledge of US FDA/EMA drug/device development process, regulations and guidelines, including GCP. Solid knowledge of Quality Assurance and PAI preparations
  • Good understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP and GLP requirement and SOP’s
  • Good conceptual, strategic, analytical, problem solving, and organizational skills
  • Ability to operate independently and proactively, to provide insight into specific regulatory issues within the context of the ongoing and future programs. To proactively undertake background research needed and to propose effective and creative solutions
  • High emotional intelligence, sound temperament and professional attitude. Good common sense and judgment. Broad business perspective to integrate Regulatory Affairs concepts as part of the overall corporate strategy
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales and marketing, and administration
  • Outstanding leadership and management capabilities to build, motivate and manage a strong quality organization. Personal alignment with Rakuten Aspyrian’s values, mission and vision
  • Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done
  • Department: Regulatory and Leadership
  • Type: Full-time
  • Min. Experience: Executive

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A Note from Our Chairman

In 2012, my father was diagnosed with pancreatic cancer. I was ready to do anything for him to be cured. With that sole purpose, I read many scientific papers from all over the world, and I met and talked with numerous experts in the field. How could I cure my father’s cancer? I searched every single possibility available.

That is when I found out about photoimmunotherapy that was only at an early stage of research. Although I had many doubts about this completely new approach, desperate for a miracle, I immediately went to meet the researcher.

Everyone was still doubtful at that stage. But the more I heard about this research, the more it made sense. 

I instinctively thought, “This is it.” It was the same feeling I got as when I grasped that the internet would change the world forever. Somehow, wishing to save my father, I immediately made up my mind to support the research personally to speed it up.

Unfortunately, we didn’t make it in time to save my father. But I decided to continue my support. My father who was as an economist always said, “One important mission of corporations is to contribute to humanity.”

Left behind, I resolved to provide this latest treatment to as many people as possible. It will surely be a path fraught with difficulties. But right at this moment there are many who are suffering from cancer, many who wish to save the lives of their loved ones, and I know exactly how they feel.

To provide this treatment as soon as possible, to bring this treatment to as many people as possible, I will not fail to support this research from now on.

Chairman, Rakuten Aspyrian, Inc.

Hiroshi Mikitani

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