Associate Director / Director, Clinical Development
Location: South San Francisco, CA
Position type: Full-time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immune-oncology protein therapeutics for patients with serious unmet medical needs. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development.
We currently have three protein therapeutics in clinical trials:
- FPA008 – a monoclonal antibody that inhibits the CSF-1 receptor and is being studied in multiple tumor settings and pigmented villonodular synovitis (PVNS)
- FPA144 – a monoclonal antibody targeting FGFR2b for selected gastric cancers
- FP1039 – a FGF ligand trap for mesothelioma
On the strength of our unique discovery platform and capabilities, we have entered into strategic collaborations with leading global pharmaceutical companies. We currently have three active research collaborations with Bristol-Myers Squibb, GlaxoSmithKline and UCB Pharma, S.A.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. These values are reflected in our people and our products. We value our culture of openness, collaboration and productivity. Discover more about Five Prime at www.fiveprime.com.
The Associate Medical Director/Medical Director will report to the Senior Director of Clinical Development and matrix with members of the project team to assist in establishing the clinical development strategy for one or more compounds: from the pre-IND setting to pivotal trials and registration. Key aspects of the development strategy include study design, tissue sample collection, input to biomarker strategies, and integration of “personalized medicine” into the clinical development plan. The position is accountable for medical monitoring and patient safety and to provide medical guidance during the design, execution, and reporting of clinical studies and registration with health authorities.
Technical responsibilities required but not limited to:
- Lead the formulation of clinical development plans, including selection of the proof of concept indications for specific projects.
- In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine, research), be responsible for the design of protocols and conduct of data review, analysis and interpretation.
- Function in the role of medical monitor.
- Ensure the medical and scientific quality of clinical trial protocols, case report forms, data and data listings, and clinical trial reports.
- Be accountable for safety across relevant studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
- Work closely with CRO, Clinical Operations and investigators/investigative sites to ensure data quality and patient safety.
- Maintain working knowledge of GCPs and regulatory requirements relating to clinical development and safety compliance with ethical, legal and regulatory standards.
- Participate in proposal generation, feasibility assessments, and review of proposals/contracts for medical services.
- Participate in the development and delivery of protocol training for investigator site and FivePrime staff.
- In conjunction with the CMO and Research group, prepare strategy presentations, present and discuss data at relevant team, governance, executive committee, external consultant, KOL, and regulatory meetings.
- Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
- Participate in preparation for and conduct of meetings with healthcare authorities.
- Contribute to the overall strategy and preparation of documents to secure approval of drugs, e.g., BLAs/NDAs/MAAs.
- Lead or assist in preparation of manuscripts, abstracts and meeting presentations.
- In conjunction with Clinical Science and Operations, be responsible for the on-time and within-budget execution of protocols.
- Other projects as needed
Education and Experience:
- Requires MD with a minimum of 3-5 years of demonstrated knowledge and experience in clinical research, preferably in an industry setting.
- Strong basic science knowledge to enable proof-of-concept and PD biomarker design and interpretation.
- Oncology fellowship training and active board certification within the last 5 years.
- Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Demonstrated scientific productivity (publications, abstracts, etc.).
- Scientific writing skills and good communication skills.
- Flexibility to work with colleagues in a matrixed setting.
- Able to engage in work-related travel approximately 20%.
Please upload your cover letter and resume