Join Rakuten Aspyrian

DOCUMENT CONTROL SYSTEM ADMINISTRATOR

Location: San Diego, 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 program

Location: San Diego, 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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RECRUITER/SENIOR RECRUITER

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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SENIOR MANAGER QUALITY ASSURANCE – ANALYTICAL

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. The Sr. Manger QA (Analytical) – reviews and supports development, pre-commercial through future commercial release and stability quality functions. This position is responsible for quality review of drug substance, drug product and reference standard expiry/retest dating; analytical documentation (e.g. test methods, raw/original data, testing summaries, change controls, OOS/OOT investigations, deviations); stability protocols; stability reports and regulatory filings. This position also reviews and/or approves applicable CSP protocols and reports for equipment, process and method validation.

Key Duties and Responsibilities

  • Manage assigned development project(s) as quality lead
  • Review applicable project methods, procedures, protocols, reports, batch records, deviations and change controls
  • Provide timely communication of project status and any quality issues; escalate appropriately as per internal procedures, regulations and quality agreements
  • Suggest and implement compliant solutions to issues with input from team and management as required
  • Review and approve early phase method development, validation and transfer protocols and subsequent reports for compliance to internal documents, cGMP, ICH guidance documents and ensures consistency within each program
  • Review, advise, and approve development and pre-commercial stability protocols for compliance to internal documents, cGMP, ICH guidance documents and ensures consistency within each stability program
  • Review stability documentation (raw data, testing summaries, OOS/OOT investigations, deviations, change controls and CAPAs) and documenting quality review with data integrity certifications, as needed
  • Review stability data and reports according to proposed regulatory filings and ensuring programs are cGMP and ICH compliant
  • Review, advise, and approve drug substance, drug product and reference standard expiry and/or retesting dating assignments according to cGMP, ICH and internal documents
  • Generate Test Summaries and Certificates of Analysis
  • Conduct regulatory application data integrity of data and/or documents to be included in submissions
  • Work with CMC team and regulatory to ensure timely regulatory submissions
  • Prepare, review, approve and/or revise SOPs
  • Review, approve, and release clinical packaging batch records and development/clinical shipping and storage temperature excursions
  • Conduct, participate and support in-house audits as subject matter expert
  • Other duties as assigned

Desired Education, Skills and Experience

  • Bachelor’s degree in a scientific field required; advanced degree in relevant discipline preferred.
  • Thorough knowledge of cGMP and ICH requirements.
  • 10+ years of direct Quality Experience with increasing responsibilities and GMP knowledge
  • At least 2 years’ experience managing, organizing and executing stability programs.
  • Solid data review skills.
  • Strong detail orientation required.
  • Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.
  • Excellent organizational skills, and ability to prioritize workflow and to meet established timeframes
  • 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

Position Summary

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 CLINICAL DATA MANAGER

Location: San Diego, CA

The Clinical Data Manager II or Senior Clinical Data Manager (CDM II/Sr. CDM) will provide oversight of, assist in the coordination of, and partake directly in the data management activities from study start-up, data processing, and database close-out in a paper or electronic environment for projects sponsored by Aspyrian Therapeutics where the activities are conducted in-house or by CROs.

The CDM II/Sr. CDM will have advanced knowledge of GCP/ICH standards, 21 CFR Part 11, and clinical trial processes as well as and be proficient in all aspects of data management from study start-up to study close-out, have experience in multiple Electronic Data Capture (EDC) environments, experience in Phase I, II, or III oncology studies, and experience in the oversight of CROs and 3rd party data vendors; in addition, the candidate will have experience with implementing CDISC CDASH CRF Standards and CDISC SDTM mapping, as well as knowledge of ADaM datasets and clinical trial SAS programming as related to data quality edit checks, data review, listings and reports, and tables/figures/listings (TFLs) is desired.

The CDM II/Sr. CDM will report to the Manager of Clinical Data Management or Director of Clinical Data Management (depending on level hired) and work closely with the Clinical team.

Key Duties and Responsibilities

  • The CDM II/Sr. CDM is primarily accountable for the support of acquisition, transit, cleaning, reporting and overall quality of Aspyrian clinical study data from Phase I studies through Regulatory submissions. Ability to interact collaboratively cross-functionally, with external data vendors and as well as oversee CROs is a critical responsibility.The CDM II/Sr. CDM will act as the primary contact and provide oversight for all data management related activities outsourced to CROs and external vendors for one or more assigned studies.
  • Responsible for data management activities supporting Aspyrian clinical programs from DM strategy, database set-up through database lock and CSR/submission
  • Anticipate data management project requirements, institute, and manage appropriate actions to ensure timelines and project goals are met
  • Responsible for completeness, timely delivery, and quality of clinical trial data from Aspyrian programs
  • Participate in vendor evaluation, qualification, and selection, as needed
  • Serve as DM representative at study team meetings and as primary contact for internal departments and external vendors; develop, track, analyze, and provide regular status reports on vendor activities as well as internal data management performance metrics
  • Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other data vendors with respect to key performance indicators, metrics, and program level deliverables and timelines. Assess metrics for vendor quality and efficiencies, and escalate issues as needed
  • Participate in protocol design and review, providing key input related to the operationalization of the design and data collection, while ensuring consistency and that standards are followed
  • Develop or review key documents such as data collection instruments, database design specifications, Data Management Plans, Edit Check Specifications, data transfer specifications, SDTM mapping, CRF Completion Guidelines, Manual Review Guidelines, or Data Entry Guidelines
  • Develop User Acceptance Testing (UAT) plans, coordinate, and participate in UAT
  • Review site completed electronic case report forms (eCRFs) or paper CRFs for completeness and content, when applicable
  • Review or perform external data reconciliation (i.e. laboratory data), and SAE reconciliation
  • Proactively organize and perform on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, and quality issues
  • Ensure proper closeout and archiving of data management study related materials, i.e. DMPs, database change documentation, validation documents, and final patient casebooks in paper or electronic format
  • Ensure compliance with all applicable laws, regulations, and regulatory guidelines
  • Understand and follow applicable Aspyrian SOPs. May contribute to the development and implementation of data management department policies, standards, and process improvement initiatives
  • Provide leadership, training, and support to new Aspyrian Data Managers as department grows
  • Keep abreast of literature and advancements in data management technologies, standards, and best practices while informing Aspyrian Clinical so they may be considered and/or applied to Aspyrian drug development programs.
  • Perform other duties as assigned by management.

Desired Education, Skills, and Experience

  • University/college degree is required, major in life science preferred
  • Minimum 5 years of relevant research, pharmaceutical, biotech, or CRO experience in data management
  • Must be proficient in all aspects of data management from study start-up to study close
  • Knowledge of medical terminology, coding processes using MedDRA and WhoDRUG, and database design concepts
  • Working knowledge of ICH, FDA, CFR, GCP, HIPAA, GCDMP regulations and guidelines, as well as CDISC CDASH standards and SDTM/ADaM specifications
  • Excellent organizational skills with great attention to detail and the ability to multitask
  • Excellent verbal and written communication skills, as well as inter-personal skills and oral presentation abilities
  • Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments (e.g. Regulatory, Clinical Operations, Medical, Safety, CMC, Pre-Clinical, Stats, etc.)
  • Ability to work proactively and effectively in a fast paced, high change environment
  • Demonstrated initiative and resourcefulness
  • Ability to represent Aspyrian in a professional manner
  • Assumes responsibility and accountability for results
  • Proficient computer skills including MS office products
  • The qualified applicant must be flexible, well-organized, and can work well under pressure and prioritize.

Location: San Diego, CA
Department: Clinical
Type: Full-time
Min. Experience: Some Experience

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DIRECTOR OF SCIENTIFIC COMMUNICATIONS

Location: San Mateo, CA

The Director of Scientific Communications will lead the successful development and execution of the communications strategy and publication plan(s) for Rakuten Aspyrian products. He or she will oversee the timely implementation of the publication plan and the creation, coordination, tracking and execution of scientific materials (manuscripts, abstracts, posters, and slide presentations). The Director of Scientific Communications will ensure quality and compliance of these deliverables. He/she will demonstrate scientific/research expertise in the appointed therapeutic area and will build strong working collaborations with both internal and external personnel to ensure quality data analysis, interpretation, and communication.

Key Duties and Responsibilities

  • Responsible for the creation and implementation of the communications strategy and publication plan(s)
  • Lead the execution of scientific deliverables including abstracts, posters, oral presentations, manuscripts and slide decks
  • Ensure compliant development and review of publications/presentations that reflect global publication guidelines
  • Plan, develop and implement educational plan, and other scientific programs that communicate important information to the medical and scientific community
  • Establish strong collaborative relationships with key internal and external stakeholders
  • Manage all aspects of publication and medical communication agencies but not limited to identification, screening, management and supervision these agencies and manage all financial and contractual aspects of assigned projects
  • Select and manage the data repository for scientific communications
  • Creation of departmental policies/SOPs necessary to achieve organizational objectives and for complying with government regulations
  • Ensure compliance with legal, regulatory and industry standards for scientific communications (e.g ICMJE, GPP3 and Pharma codes) and has a strong understanding of publication practices and guidelines
  • Manage annual budget and evaluates resource requirements for the scientific communications department
  • Other duties as assigned

Desired Education, Skills and Experience

  • Advanced degree: PhD, PharmD, or MD
  • Minimum 7 years of relevant experience in a pharmaceutical company including a minimum of 3 years of experience in leadership roles
  • Demonstrated skilled expertise in writing, editing, and managing scientific materials (e.g. abstracts, manuscripts, poster presentations)
  • Strong experience in strategic publication planning (including scientific platforms), tactical publication planning and implementation, and the planning and development of medical educational materials
  • Ability to interpret and organize highly complex scientific data, including experience reviewing clinical trial data and output from statistical analysis programs
  • Experience in working closely with KOLs and authors
  • Experience in planning and implementation of symposia preferred
  • Demonstrated leadership skills
  • Understanding of good publication practices and guidelines, ie, ICMJE, GPP3, etc. Familiarity with AMA style guidelines. Knowledge of FDA, EMA, and ICH guidelines. Deep understanding of the drug development process and prior experience in the biopharmaceutical industry
  • Excellent communication, time management and project planning skills
  • CMPP and/or AMWA certification desired
  • Disciplinary expertise in oncology preferred
  • Ability to travel as necessary

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

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

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DIRECTOR/SR. DIRECTOR CLINICAL GCP QUALITY

Location: Tokyo, Japan

The Director/Sr. 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 15+ years of experience in clinical quality and process improvement. The candidate will have an excellent working knowledge of Good Clinical Practices, and quality requirements and regulations in Japan and other Asia Pacific countries, such as Korea and Taiwan. In addition, knowledge of other international regulations (e.g. US FDA, EU) 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
  • Direct 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 15 years of pharmaceutical and/or biotech experience with at least 12 years direct experience in Quality Assurance, GCP and Compliance
  • 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 highly preferred
  • GMP 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 20-30%, but at times may be higher based on business needs

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

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MANAGER, FINANCIAL PLANNING & ANALYSIS

Location: San Mateo, CA

The Manager, FP&A and Accounting will be responsible for developing and managing the Financial Planning & Analysis (“FP&A”) system and function. In addition, they will be performing balance sheet account reconciliations, reviewing international subsidiary accounting and consolidations, and other accounting functions. Ideal candidates will have at least 3 years of public accounting experience and three years of experience at a biotech company in this role. CPA or MBA required.

Key Duties and Responsibilities

  • Implement a FP&A web based budget software system
  • Partner with department heads to prepare the annual budget and strategic plan
  • Develop and distribute financial operating results including variance reporting of actuals to budgets and prior periods
  • Prepare financial analysis to support business requirements or decision making
  • Prepare balance sheet account reconciliations and associated journal entries for prepaid expenses, accrued expenses, etc.
  • Review financials for two international subsidiaries and prepare intercompany entries
  • Maintain fixed asset and depreciation schedules
  • Complete other projects related to accounting and finance
  • Other duties as assigned

Desired Education, Skills and Experience

  • CPA or MBA required
  • Minimum of three years in public accounting and knowledge of US GAAP
  • Minimum of three years experience at a biotech company in this role
  • Bachelor’s Degree in Accounting or Finance required
  • Experience with Adaptive Insights or Host Analytics budgeting software required
  • Experience with Great Plains accounting software preferred
  • Ability to bridge communication between Finance and R&D
  • Excellent organizational skills and ability to meet deadlines
  • Excellent verbal and written skills
  • Process improvement mindset
  • Exceptional self-management ability

Location: San Diego, California
Department: Finance
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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TECHNICAL OPERATIONS ASSOCIATE – CELL CULTURE

Location: San Diego, CA

Rakuten Aspyrian is currently looking for a highly motivated individual to support cell culture process development, manufacture, and technology transfer to CMOs. This candidate will join Aspyrian’s CMC team focusing on various aspects of upstream cell culture process development, process characterization, technology transfer and research material generation. In addition, the ideal candidate will be familiar with processes related to the development, characterization and manufacture of antibody drug conjugates (ADCs).

Key Duties and Responsibilities

  • Key responsibilities include the development, optimization, technology transfer, scale-down model development and process characterization of upstream cell culture and conjugation processes
  • Participate in cell line development activities for material generation as needed to support analytical development, formulation development, stability programs, and in-vivo animal studies
  • Provide support for transient gene expression activities including, purification and conjugation of critical research reagents
  • Candidate will be responsible for the maintenance, calibration and troubleshooting of all cell culture related equipment to support development activities and small-scale material supply efforts
  • Responsible for the preparation of buffers and media and other required reagents as needed to support in-house cell culture and conjugation activities
  • Responsible for ordering and maintaining raw materials, lab supplies and providing oversight to inventory of all required reagents
  • Support the expansion of an internal cell culture lab, including bioreactor selection and installation, as well as the incorporation of supporting analytics
  • Participate and provide input into the optimization of workflows related to cell culture and conjugation activities
  • Candidate would participate in raw materials and/or equipment specifications, new equipment integration, new product integrations, and process data trending
  • Participate in statistical design and analysis of process characterization and qualification activities
  • Author technical documents and reports to support cell culture and conjugation activities
  • 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
  • Other duties as assigned

Desired Education, Skills and Experience

  • BS/MS with >4 years of experience in upstream biopharmaceutical development, manufacturing, bioengineering or related discipline
  • Experience working with recombinant proteins, antibody drug conjugates and related analytical techniques is required
  • Experience in purification and filtration (tangential flow filtration, ultrafiltration and diafiltration) operations highly desirable
  • Understanding of cGMP manufacturing and associated regulatory requirements
  • Experience with monoclonal antibody processes through development, clinical and commercial scales is preferred
  • Statistical understanding of design of experiments (DOE) and the resulting datasets is preferred
  • Understanding of non-antibody processes and regulatory experience is desired
  • Attention to detail, innovative thinking and ability to work well in multidisciplinary teams is required
  • Candidate must be able to work effectively communicate and present ideas and results in a cross-functional team environment

Location: San Diego, California
Department: Manufacturing
Type: Full-time
Min. Experience: Some Experience

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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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CLINICAL TRIAL MANAGER

Location: San Diego, CA San Mateo, CA

The 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 Diego or San Mateo, CA
Department: Clinical
Type: Full-time
Min. Experience: Senior Level
*This role can be based out of San Mateo, CA or San Diego, CA

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CLINICAL SUPPLY CHAIN SPECIALIST/MANAGER

Location: San Mateo, CA

We are looking for a seasoned Clinical Supply Chain Specialist or Manager is responsible for managing investigational drug, devices, and ancillary supplies for assigned clinical studies, in coordination with Clinical Supply Chain, Clinical Operations, CMC, Regulatory, Quality, and Finance teams. The ideal candidate will have 5+ years of experience in clinical supply chain management, with global experience preferred. The Clinical Supply Chain Specialist or Manager will be assigned at the study level, with the opportunity to manage multiple studies as the program size warrants. The candidate will have an excellent understanding of the drug development process and be able to independently forecast and manage supply and distribution needs for assigned clinical studies.

Key Duties and Responsibilities

  • Effectively manage/oversee both investigational drug and device supply chain for assigned clinical studies, including budget forecasting, sourcing, forecasting, and import/export activities
  • Implement and manage IXRS/IRT systems for assigned clinical studies
  • Manage supply depots in global clinical trials for inventory, distribution, expiry management, returns, and destruction
  • Manage calibration and service calendars for devices
  • Develop metrics to monitor and analyze clinical supply chain effectiveness
  • In collaboration with QA and the Sr. Manager of Clinical Supply Chain, write and review department Standard Operating Procedures (SOPs), as warranted to support good Quality practices
  • Other duties as assigned

Desired Education, Skills and Experience

  • Bachelors or Masters degree in the Life Sciences, Supply Chain Management, Industrial Engineering, or related field
  • Minimum 5 years of experience in clinical supply chain management
  • Demonstrated ability to work independently and with cross-functional teams, including Clinical Supply Chain, Clinical Operations, CMC, Regulatory, Quality, and Finance teams
  • Proficiency in GMP/GCP processes, labeling, and import/export requirements for clinical supplies
  • 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: Clinical Supply Chain
Type: Full-time
Min. Experience: Some Experience

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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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MEDICAL WRITER

Location: San Mateo, CA

It is the Medical Writer’s role to manage various writing activities in coordination with the Clinical/Medical team. The Medical Writer will ensure consistency across documents, improve document quality and provide guidance on writing style. The Medical Writer will assist in the writing and review of publications, abstracts and clinical trial-related documents. The ideal candidate will have 7 + years of medical writing experience in a similar environment.

The Medical Writer will report to the Chief Medical Officer and work closely with the Clinical team.

Key Duties and Responsibilities

Manage medical writing activities by identifying contributors, reviewers and maintaining agreed upon timelines

  • Plan, write, edit, format, and finalize clinical program and trial-related documents, including but not limited to, IB, protocol/amendments, consent, clinical study reports, statistical analysis plans, along with Tables/Listings/Figures, regulatory submission documents including annual reports, and publications/abstracts/presentations)
  • Performs on-line clinical literature searches as needed
  • SOP and Guidance review and writing
  • Experience in developing style writing manuals or similar; familiarity with the AMA style guide
  • May also participate in R&D and other departmental writing/review activities as time allows
  • Work effectively across functional teams and represents medical writing
  • Other duties as assigned.

Desired Education, Skills, and Experience

  • Bachelor’s or Master’s degree in the science or writing discipline
  • Minimum 7 years related medical writing experience in biotech or similar environment
  • Demonstrates strong writing skills with sample work
  • Extensive knowledge of federal regulations, Good Clinical Practices, ICH-E3 and other guidance, as well as applicable US/International regulatory processes related to document preparation and production (including eCTD).
  • Broad knowledge of clinical development and statistics applications to the presentation of clinical data is a plus
  • Demonstrates strong organizational skills and ability to work well in a cross-functional team environment
  • Knowledgeable on documentation requirements for manuscript submissions to scientific and medical journals
  • Maintains familiarity with current industry practices, regulatory requirements, and guidance that affect medical writing
  • Strong ability to read, write and interpret the English language
  • Strong attention to detail
  • Strong proficiency in Word, Excel, PowerPoint, the use of templates, email and internet

Location: San Mateo, California

Department: Medical Writing and Clinical

Type: Full-time

Min. Experience: Senior Level

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CLINICAL QUALITY MANAGER

Location: San Diego, 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 Diego, CA
  • Department: Clinical
  • Type: Full-time
  • Min. Experience: Manager

 

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Regulatory Affairs Head, Oncology

Location: San Mateo, CA

The Regulatory Affairs head 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 Regulatory Affairs head will work directly with 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 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 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 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 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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