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Astellas Pharma Associate Director, Clinical Science in San Francisco, California

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

Our Values

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

The Associate Director, Clinical Science position plays a key role in our Clinical Development department. The role is for a scientific expert in molecular biology that strategically supports the research and business objectives of several therapeutic areas across the product life cycle. This role will require a thorough understanding of molecular biology, cell biology, signal transduction, biochemical techniques, and translational biomarkers to support analysis and clinical interpretation of study outcomes. This role will collaborate closely with the Astellas Gene Therapies cross functional team including Clinical Development, Clinical Operations, Bioanalytics, Non-clinical, Regulatory Affairs, Biometrics, and Quality Assurance and support vendor/laboratory selection and oversight. The Associate Director, Clinical Science will ensure alignment on DNA-, RNA-, and protein-based assessments between clinical strategy and clinical study protocols, operational structure, and operating procedures. The candidate will be responsible for ongoing data analysis, interpretation, summarizing study results for preparation of regulatory documents and publications/presentations, and supporting project teams with scientific information and progress updates related to the assigned clinical studies. Other responsibilities will include providing expert input to clinical development related documents including study synopses and protocols, study manuals, charters, investigational brochures, clinical study reports and documents that support development and execution of clinical studies.

The ideal candidate would possess advanced problem solving and analytic skills. This position will be based in our San Francisco office.

Responsibilities:

  • Clinical Science

  • Develop DNA-, RNA, and protein-based assays and project deliverables within study timelines, while enforcing strict GxP compliance.

  • Provide expertise in the analysis and interpretation of DNA-, RNA-, and protein-based test results to integrate with the overall clinical studies.

  • Identify, recommend, help implement, and troubleshoot various assays for clinical trial sample testing of gene therapy-based therapeutics.

  • Collaborate with Bioanalytics and CRO's and serve as an expert in assuring successful method implementation, preparation of sample analysis plan and other study related documentations, provide scientific monitoring and ensure the quality and integrity of the data obtained during clinical sample assessments.

  • Author and review method related and clinical sample testing documentation for regulatory submissions.

  • Conducts review of published literature and clinical and preclinical reports in the field to provide the context for clinical development programs.

  • Author relevant sections of clinical documents and publications pertaining to DNA-, RNA-, and protein-based assays and clinical data (e.g. Clinical Protocols, Clinical Study Reports, Investigator Brochures, study manuals, charters, abstracts and manuscripts) and documentation for submission to regulatory agencies.

  • Author relevant sections of internal reports pertaining to operations, sample management, data transfer, analysis and interpretation.

  • Contribute to the preparation of sections of IND/BLA documents and in addressing questions and inspections from the regulatory agencies.

  • Provide clinical input into statistical planning and lead data analysis and interpretation of the DNA-, RNA-, and protein-based study endpoints.

  • Maintain strong scientific knowledge and awareness of advances in the field of molecular biology as it related to gene therapy and neuromuscular diseases.

  • Clinical trial support

  • Support research initiatives across development for site evaluation and identification recruitment, investigator meetings, opinion leader identification, and Investigator initiated studies management.

  • Provide scientific input to protocol development and definition of safety endpoints for Phase 1, 2 and 3 clinical trials.

  • Coordinate closely with Clinical Operations to develop clinical trial laboratory manuals, train clinical site staff, and monitor sample testing.

  • Relationship management

  • Support vendor/laboratory engagement and oversight to ensure data quality and integrity.

  • Serves as a scientific resource to medical affairs and commercial partners as appropriate to support activities such as advisory boards, investigator meetings, and training initiatives including preparation and delivery of presentations.

  • Identifies, gains access to, and develops professional relationships with targeted Key Opinion Leaders (KOLs), external partners such as clinical investigators, clinicians, scientists, and vendors in therapeutic areas of commercial and research interests.

  • Provides education relative to disease state and products across the product lifecycle to healthcare providers and researchers.

Must Have/Required

  • A PhD in Molecular Biology, Genetics or related field with 10+ years of clinical, scientific/research or industry related experience.

  • Strong scientific background and experience in molecular biology techniques (qPCR, RT-qPCR, ddPCR, RNAseq, NGS), in vitro and cell-based assays, and protein based assays (construct design, cell culture, purification, ELISA, Western Blot, enzymatic assays, protein-protein interactions, liquid chromatography, mass spectroscopy)

  • Strong practical knowledge of method development, troubleshooting, validation and of bioanalytical regulatory and industry guidelines.

  • Breadth of knowledge of different areas of life sciences, awareness of new technologies, and familiarity with current issues to apply novel and innovative approaches to problem solving.

  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.

  • Direct experience coordinating trial activities, in clinical sample management and biomarker analysis.

  • Proven scientific leadership when working with collaborative, multi-functional teams.

  • Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.

  • Demonstrated experience authoring submissions documents to regulatory agencies.

  • Proficient in complex data analysis, bioinformatics, and in the use of statistical software (SigmaPlot, GraphPad, JMP, R, etc.).

  • Excellent and effective written, verbal communication and presentation skills.

  • Ability to travel up to 20% domestic and international.

  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

May Have/Preferred

  • Experience/education with therapeutic knowledge in gene therapy products.

  • Experience in conducting clinical trials in rare diseases in the neuromuscular disease area

  • Continually educates self on global market issues / trends and product knowledge as it pertains to specific business responsibilities in key therapeutic areas.

#LI-LK

Category Clinical Development

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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