Clinical Program Manager / Senior Clinical Program Manager
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.
We are seeking a highly motivated Clinical Program Manager (CPM) to collaborate with the Clinical Development Team (CDT) in the conduct of clinical trial activities. The CPM is accountable for independently managing the full scope of assigned clinical trial(s)/program and leading cross-functional team(s) and vendor efforts to ensure Five Prime clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, applicable regulations, and ICH/GCP guidelines. This position will report into the Associate Director of Clinical Operations.
- Manage a group of related clinical trials within a molecule program; manage and communicate program timelines, budget, resources, and clinical activities and priorities. Proactively identify and mitigate program risk
- Represent Clinical Operations on the Clinical Development Team (CDT); provide operational expertise and strategic input into the Clinical Development Plan (CDP) for assigned studies/program). Ensure CDT decisions and priorities are communicated to the Study Execution Team (SET) and Clinical Operations staff.
- Lead and collaborate with cross functional team(s) including the SET to ensure that scientific objectives of the CDP are met. Oversee the conduct of study activities for assigned programs.
- Oversee identification, selection, onboarding and management of study vendors including CROs, central /specialty labs, and imaging vendors. Provide study-specific training and direction/oversight to CROs, labs and vendors to ensure delivery against scope of work and key performance indicators.
- Partner closely with Clinical Development and other Functions to design and write clinical trial protocols. Oversee cross functional activities and SET and program level deliverables (e.g. DSUR, IBs, protocols, ICFs, CRFs, and CSRs.)
- Review and approve study management plans (e.g. vendor oversight, TMF oversight, risk management, quality management, and monitoring) to ensure. Ensure team adheres to plans and conducts studies in accordance with ICH GCP and applicable regulations.
- Oversee and partner with external and internal stakeholders to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise ‘quality assured’
- Oversee implementation of clinical systems and including CTMS, TMF, EDC, IxRS, and sample management for assigned clinical trials
- Manage program budget; ensure accurate and timely review of invoices and payments, monthly accruals and forecast budget variances.
- Develop and oversee study quality metrics
- Proactively drive SET deliverables and identify opportunities to accelerate programs
- Partner with Director/ Associate Director to develop and implement operational strategy for assigned clinical trials (country selection, site selection, vendor selection, study timelines and budget)
- Participate in recruiting, hiring and training Clinical Operations staff. Effectively delegate activities and oversee Clinical Operations team deliverables. Coach and mentor direct reports (i.e. CTMs/CTAs).
- Lead departmental process initiatives
- Other projects as needed
Education and Experience
- BA/BS degree, preferably in the life sciences; advance degree preferred.
- 8+ years (CPM)/10+ years (Sr. CPM) of experience in all phases of clinical drug development filing INDs and NDAs/BLAs, 6+ years (CPM)/8+ years (Sr. CPM) with Masters or PhD.
- Proven ability to lead cross functional teams
- Excellent interpersonal and written communication skills
- Proven ability to successfully plan, implement, and manage multiple clinical trials for a molecule
- Prior line management and program budget management (Sr. CPM)
- Prior CRO and vendor management skills is a must
- Strategic agility and flexibility
- Excellent working knowledge of FDA & ICH/GCP regulations and guidelines
- Ability to travel internationally up to 25%
Please upload your cover letter and resume.