Executive Director/ Vice President, Clinical Development
Location: South San Francisco, CA
Position type: Full-time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to alter the tumor microenvironment to enhance tumor cell killing. Our company has a growing portfolio of product candidates and currently has three protein therapeutics in clinical development.
- Cabiralizumab (FPA008) – a monoclonal antibody targeting CSF1R in a Phase 1/2 clinical trial in pigmented villonodular synovitis (PVNS) and in a Phase 1a/1b clinical trial in multiple cancers in combination with Bristol-Myers Squibb Company’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab)
- FPA144 – a monoclonal antibody targeting FGFR2b in a Phase 1 clinical trial in FGFR2b over-expressing gastric cancer
- FP-1039 – an FGF ligand trap in a Phase 1b clinical trial in mesothelioma
Five Prime has a differentiated target discovery platform and library that we use to rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models to discover novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple collaborations with pharmaceutical companies, including Bristol-Myers Squibb, UCB Pharma, S.A. and GlaxoSmithKline across a range of therapeutic areas. FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
Reporting to the Chief Medical Officer, the position will be responsible for leading the clinical elements of development of multiple projects within the organization. This will be both through hands-on leadership of early stage projects, partnering with Research on early pipeline strategies, and working closely with Business Development to assess potential in-licensing product candidates. The position will also develop, over time, as direct line management of Medical Directors running clinical programs, Drug Safety, or other key Clinical Development hires.
The position is responsible for working collaboratively with members of the development team in establishing the clinical development strategy for one or more compounds anywhere from the pre-IND setting to pivotal trials and registration. The position may require hands-on accountability for medical monitoring and patient safety and to provide medical guidance during the design, execution, and reporting of clinical studies, until a project team is fully staffed. The candidate will work within the project team structure, sitting on core project teams to guide strategy, and working within relevant sub-teams to ensure tactical alignment and execution.
- The optimal candidate will demonstrate leadership qualities with significant knowledge and experience in developing Phase 1 & 2 protocols, analyzing pharmacokinetics, safety and efficacy data and advancing pharmaceutical large molecules (biologics) through preclinical, clinical stages, BLA/NDA submissions, and Advisory/Scientific Committee Meetings. The candidate will have authored relevant sections of regulatory submissions for INDs, CTAs and global filings and, ideally, will have an established a track record of publishing articles and abstracts in professional journals.
- Apply subject matter expertise towards formulation of clinical development plans, including selection of the proof of concept indication.
- In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine), is responsible for the design and authorship of study protocols and interpretation of clinical study data.
- Conduct medical monitoring and data listing reviews as necessary
- Work closely with Clinical Operations colleagues on study implementation and oversight, which includes site and CRO selection and investigator meeting preparation.
- Accountable for safety across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
- In conjunction with Development colleagues, prepare strategy presentations, present and discuss data at relevant team, governance, 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
- Participate in the development and delivery of protocol training for investigator site and FPRX staff.
- Educate team members and vendors on the molecule and disease area and participating in internal continuing education activities
- Contribute to the clinical development plan for one or more compounds, including review of the pre-clinical package after soliciting appropriate input, review and endorsement from key stakeholders for go/no-go development decision criteria
- Assume the clinical leadership role for a project, representing the medical function on the project team and representing the team for medical discussions with the Development Committee
- As a member of the project team, interface with Statistics, PK/PD, Regulatory, Clinical Operations, Diagnostics, Translational Medicine, Project Team Leadership and Management and other members of the extended project team(s).
- In conjunction with the Clinical Operations, is responsible for the on-time and within-budget execution of protocols.
- May have functional responsibility for other clinicians or clinical scientists assigned to the project and may supervise and develop other colleagues, such as Drug Safety.
- Organize and prepare for Advisory Board meetings
- Act as clinical representative for in-licensing activities such as due diligence reviews, reports, and development strategies.
The VP will have a documented track record of achievements from early clinical development through phase III studies, across different therapeutic modalities. He or she will possess a solid understanding of US and international regulatory authorities and the drug approval process, including the application of biomarkers to drug development and approval. Possessing the ability to build consensus on trial design, working effectively with opinion leaders, investigators, and regulatory colleagues, he or she will use clinical perspective to design, prepare and initiate study protocols and other required documentation in compliance with project plans, regulatory requirements and GCP. The candidate will also analyze and interpret study data; prepare and present study status and strategy to company management; and, prepare reports for FDA submission and publication. Close engagement with the translational medicine function is mandatory, and a deep understanding of how “biomarkers” can be applied to accelerate drug development, and drive early go/no-go decisions is critical.
- MD with a minimum of 10 years of demonstrated knowledge and experience in clinical research in an industry setting.
- Oncology training required with 3-5 years in practice
- Prior management experience leading a team of Medical Directors and/or senior Scientists
- Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Demonstrated scientific productivity (publications, abstracts, etc.).
- Proven scientific writing skills and good communication skills
The VP will be a dynamic and innovative clinician scientist with a well-developed sense of teamwork. He or she will have the interpersonal skills required to communicate effectively with external collaborators and international internal project teams. The individual will also be a well-respected mentor through coaching, respect, honesty, humanity and daily practice of lead-by-example.
The Clinical Development team within FivePrime is a fast-moving team, with a sense of urgency around what we do. Successful colleagues can manage ambiguity and uncertainty successfully, and can develop and execute project plans within a busy environment where competition for resources will exist. A focus on the necessary and critical, versus the “nice to have” is essential – this requires knowledge, experience and good judgment as well as an ability to align others with your point of view. We are an effective organization, and FivePrime is a very stimulating and enjoyable place to work.
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