Join Rakuten Aspyrian

SENIOR MANAGER/ASSOCIATE DIRECTOR OF MEDICAL AFFAIRS

Location: San Mateo, CA

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

Key Duties and Responsibilities

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

Desired Education, Skills and Experience

  • Advanced degree, e.g. PhD, PharmD, or MD required
  • Minimum 3-6 years of relevant experience in a pharmaceutical or biotechnology company including a minimum of 2-3 years of experience in medical affairs required
  • Promotional materials review committee experience and expert knowledge of pharmaceutical promotional regulations and standards is required
  • Medical Information experience is required
  • Prior involvement with IIRs/Collaborative research and Expanded access preferred
  • Experience in planning and implementation of advisory board preferred
  • Excellent communication, written, verbal and presentation skills
  • Proven ability to review, interpret and present complex scientific data
  • Analytical and problem-solving skills; detail-oriented, independent and critical thinker
  • Ability to multi-task and shift priorities quickly while working under tight deadlines
  • Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction
  • Experience in working closely with KOLs and investigators
  • Demonstrated leadership skills
  • Must be committed to full compliance with all company SOPs, regulatory requirements, and applicable laws including PhRMA guidelines
  • Proficient with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems
  • Excellent time management and project planning skills
  • Disciplinary expertise in oncology preferred
  • Up to 30% travel

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

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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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REGULATORY AFFAIRS MANAGER

Location: San Diego, CA

The Regulatory Affairs Manager will report to the Director of Regulatory Affairs and will be responsible for supporting the development and implementation of regulatory strategies with a goal to ensuring timely clinical study starts and execution, CMC development, and BLA readiness for Aspyrian’s biologic/drug combination therapies. The Regulatory Manager will work closely with other functions of the company, including Quality Assurance, Clinical Affairs, Supply Chain, CMC, and Program Management.

The ideal candidate will have good understanding of GCP, GMP, and GLP and be able to advise teams regarding these and other country-specific health authority regulations. The candidate should have experience with filing INDs and CTAs and with coordinating and responding to health authority questions related to those filings. The candidate should have sufficient drug development experience to advise teams regarding development activities and documentation needed for a successful marketing application.

Strong organizational and writing/reviewing skills, excellent interpersonal/teamwork skills, and an ability to be flexible and work in a fast-paced environment with tight timelines are required.

Key Duties and Responsibilities

Regulatory Affairs Manager will be responsible for:

  • Assisting with strategy development for global regulatory filings (INDs, CTAs, CTNs, BLAs)
  • Compiling list of data required, submission content, and templates for regulatory filings
  • Working with Subject Matter Experts to compile data and content for regulatory filings and ensuring that regulatory documents are written per timelines
  • Reviewing regulatory filings to ensure data is appropriate, scientifically sound, and presented in a clear and concise fashion
  • Working with contractors to ensure regulatory submissions are formatted, published, and filed in a timely fashion
  • Tracking filing submission dates, questions from Regulatory Health Authorities, responses, and approval dates
  • Working with Quality to ensure country-specific requirements and regulations are managed and tracked
  • Tracking new quality, CMC, nonclinical, and clinical regulations and guidances and disseminating knowledge to colleagues
  • Work with SMEs to ensure delivery of high quality documentation to meet global regulatory expectations with proper storage and retrieval capabilities
  • Other duties as assigned

Desired Education, Skills and Experience

  • Minimum of 3-5 years of regulatory experience or equivalent combination of pharmaceutical development and regulatory affairs experience
  • B.S./M.S. or higher degree in a life or physical science
  • RAC accreditation is desirable
  • Extensive knowledge of FDA/EMA biologic development requirements, regulations, guidances
  • Excellent organizational skills, ability to work collaboratively in a team environment, and ability to meet deadlines
  • Excellent knowledge of GMP, GCP, GLP and FDA, EMA, and ICH regulations and guidance documents
  • Knowledge of device guidance and IDE, 510(k) and PMA requirements desirable
  • Ability to operate independently and proactively

Location: San Diego, CA
Department: Regulatory
Type: Full-Time
Experience: Manager

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RECRUITER – BIOTECH

Location: San Mateo, CA

Rakuten Aspyrian is growing rapidly to support the next stages of development of our technology. We are looking for an accomplished Recruiter to join and build our team in our San Francisco Bay Area office. The Recruiter will provide an innovative best-in-class candidate experience and quality support to our Talent Acquisition team.

This person will also be a key member of the culture engine. The Recruiter contributes to the objectives that will provide an employee-oriented, high-performance culture that emphasizes empowerment, quality, productivity, goal attainment, and the recruitment of an outstanding workforce.

Key Duties and Responsibilities

  • Represent and drive People Operations in our new office in the San Francisco Bay Area
  • Support and execute the company’s overall recruitment strategy
  • Find and engage with top talent through advertisements, industry events, applicant review, and other sourcing methods
  • 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
  • Support the talent acquisition process including candidate communication, reporting, requisitions, job boards, and more
  • In an effort to attract the best talent, build relationships with academic institutions, local biotech community, organizations, and networks
  • Responsible for 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
  • Support the on-boarding process
  • Rakuten Aspyrian 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
  • 3+ years of recruiting experience in a pharmaceutical or biotechnology company
  • Strong understanding of talent landscape, analytics and recommendations for talent strategy
  • 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
  • Exceptional problem solving, time management, and organizational skills
  • Passionate about process improvements and outstanding customer service
  • Ability to exercise tact, discretion and the initiative to efficiently meet the demands of multiple internal partners
  • 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 Mateo, CA
Department: People Operations
Type: Full-time
Min. Experience: Some Experience

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SENIOR ASSOCIATE I/II- ANALYTICAL FORMULATION DEVELOPMENT

Location: San Diego, CA

The Sr. Associate I/II is a key member of the Analytical Formulation Development team and will be involved in supporting Aspyrian’s research and discovery programs and CMC activities. The candidate will perform HPLC, CE, ELISA and LC-MS based methods for structural characterization of Aspyrian’s first-in-class photoactivatable monoclonal antibody conjugates. The ideal candidate will have shown proficiency in hands-on analytical work and the ability to collaborate with third party testing organizations. Responsibilities include method development, routine testing, structure elucidation, structure/function assessment, and analytical support of conjugation, formulation, and development stability studies.

Key Duties and Responsibilities

  • Perform analytical characterization test methods suitable to support in-process, drug stubstance 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
  • Support upstream and downstream processes with sample management and data reporting
  • Summarize, interpret, and critically evaluate analytical data. Present results at group/team meetings
  • Maintenance and troubleshooting of laboratory equipment
  • Responsible for preparation of analytical buffers, mobile phases and inventory of critical reagents and supplies
  • 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. Assoc. I/II 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 3-5 years of analytical development experience with biologics
  • B.S./M.S. or higher degree 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), and capillary electrophoresis (icIEF, CE-SDS)
  • 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
  • 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 5% nationally and internationally, depending on analytical activities

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

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SENIOR SPECIALIST- ANALYTICAL FORMULATION DEVELOPMENT

Location: San Diego, CA

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

Key Duties and Responsibilities

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

Desired Education, Skills and Experience

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

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

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SENIOR STATISTICAL PROGRAMMER

Location: San 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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ASSOCIATE MEDICAL DIRECTOR – EUROPE

Location: Western Europe

Rakuten Aspyrian is building its Medical team to support its ongoing and upcoming clinical studies, including a global Phase III clinical study. The Associate Medical Director will be a key member of the Clinical Operations team with responsibilities to support Rakuten Aspyrian’s current clinical development program, provide medical consultation to company and project team members for clinical activities, and participate in new product development.

The ideal candidate will have an M.D., D.O. or equivalent degree, hold an active M.D. or D.O. license, and have experience in medical, surgical, or radiation oncology. Additionally, a working knowledge of drug development process, GCP, ICH guidelines and EMA regulations as well as direct involvement as an investigator of clinical studies or direct experience in managing clinical operations is highly desirable.

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

Key Duties and Responsibilities

  • Teach and observe investigators performing Aspyrian therapies
  • Provide medical oversight of clinical trials to ensure company Standard Operating Procedures, company directives and regulatory requirements are understood and followed
  • Perform medical review of clinical study reports
  • Attend and present at investigator and company meetings as needed and requested
  • Provide medical consultation to company and project team members regarding clinical trial activities
  • Participate in clinical trial development, including providing input into and/or developing materials such as target product profiles, protocols/amendments and informed consents
  • Active participation in discussions with regulatory agencies
  • Participate in new product development activities
  • Manage integration of clinical programs with regulatory strategy
  • Participate in clinical sites identification, clinical sites initiation, close-out processes and oversight of clinical sites
  • Participate in management of CROs handling clinical studies
  • Manage interactions with KOLs, etc.
  • Other duties as assigned

Desired Education, Skills and Experience

  • An M.D., D.O. or equivalent degree with active medical license
  • Oncology experience required, preferably in medical, surgical and/or radiation
  • Expertise in clinical trial design in oncology
  • Working knowledge of EMA guidelines for adverse event reporting, Federal Guidelines, GCP, and ICH-GCP
  • Familiar with EMA guidelines for Clinical Trial Authorization and other regulatory submissions
  • Understanding of clinical pharmacology with an emphasis on PK/PD of antibodies
  • 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 in English
  • 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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SR DOCUMENT QC & SYSTEMS ADMINISTRATOR

Location: San Diego, CA

As a key member of the quality team, the Senior Document QC and Systems 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 regulatory submission documents. In addition, this individual will be responsible for 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. This position reports to a Document Manager and will be responsible for establishing, arranging and maintaining all controlled documents, procedures, reports, files, training records and scanned files. This position will be the designated System Administrator responsible for establishing/managing file hierarchy and access controls.

Key Duties and Responsibilities

Essential job functions include:

  • 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.
  • Perform document control quality reviews on controlled documents (e.g., SOPs, policies, forms) within the quality document system to verify completeness, legibility, formatting, etc.
  • Maintain the document management system, including training users, activating/inactivating users, and system maintenance/optimization.
  • 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
  • 2-5 years experience administering electronic document systems
  • Experience with electronic Document/Quality Management Systems a must
  • Expert working knowledge with WORD, Excel, Adobe (including form building) and formatting documents
  • Excellent organizational skills and ability to meet deadlines
  • 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

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

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MANUFACTURING ASSOCIATE I – 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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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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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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ASSOCIATE MEDICAL DIRECTOR – USA

Location: Regional, USA

Rakuten Aspyrian is building its Medical team to support its ongoing and upcoming clinical studies, including a global Phase III clinical study. The Associate Medical Director will be a key member of the Clinical Operations team with responsibilities to support Rakuten Aspyrian’s current clinical development program, provide medical consultation to company and project team members for clinical activities, and participate in new product development.

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

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

Key Duties and Responsibilities

  • Teach and observe investigators performing Aspyrian therapies
  • Provide medical oversight of clinical trials to ensure company Standard Operating Procedures, company directives and regulatory requirements are understood and followed
  • Perform medical review of clinical study reports
  • Attend and present at investigator and company meetings as needed and requested
  • Provide medical consultation to company and project team members regarding clinical trial activities
  • Participate in clinical trial development, including providing input into and/or developing materials such as target product profiles, protocols/amendments and informed consents
  • Active participation in discussions with regulatory agencies
  • Participate in new product development activities
  • Manage integration of clinical programs with regulatory strategy
  • Participate in clinical sites identification, clinical sites initiation, close-out processes and oversight of clinical sites
  • Participate in management of CROs handling clinical studies
  • Manage interactions with KOLs, etc.
  • Other duties as assigned

Desired Education, Skills and Experience

  • An MD, DO, or equivalent degree with active medical license
  • Oncology experience required, preferably in medical, surgical &/or radiation
  • Expertise in clinical trial design in oncology
  • Working knowledge of FDA guidelines for adverse event reporting, Federal Guidelines, GCP, and ICH-GCP
  • Familiar with FDA guidelines for IND and NDA submissions
  • Understanding of clinical pharmacology with an emphasis on PK/PD of antibodies
  • 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 Research
Type: Full-time
Min. Experience: Manager

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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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