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.
Five Prime is 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.
Responsibilities include but are not limited to the following:
- Oversees implementation of clinical trials within a program outlined in the Clinical Development Plan (CDP) by managing and communicating timelines, budget (i.e. accurate assumptions and cost projections), resources, priorities, and clinical activities inclusive of proactively identifying and mitigating study/program risks
- May represent Clinical Operations on the Clinical Development Team, providing strategic input
- Supports the clinical operations management team and provides strategic input into the CDP, including assessing operational feasibility, forecasting timelines, resources and budgets, and defining the vendor outsourcing strategy for assigned studies/program
- Leads and collaborates with cross functional team(s) including the Study Execution Team (SET) to ensure that scientific objectives of the CDP are met
- Oversees and partners 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’
- Provides reports, metrics and other information to management for analysis and interpretation as needed
- Partners with management to develop corporate goals and oversees SET and clinical operations staff to achieve the established corporate goals within the expected time frames
- Oversees and at times coordinates cross functional activities and deliverables including investigator brochures, protocols, informed consent forms, CRFs, and CSRs
- Oversees implementation of clinical systems and including CTMS, TMF, EDC, IxRS, and sample management for assigned clinical trials
- Oversees onboarding and management of study vendors including CROs, central /specialty labs, and imaging vendors. Provides study-specific training and direction/oversight to team members, CROs and vendors to ensure delivery against contracts scope of work
- Solicits RFPs and identifies and selects CRO and vendors in collaboration with cross-functional on team(s)
- Partners closely with team members, vendors and Finance to review invoices, reconcile payments, accrue costs and forecast budget variances. Transparently communicates budget variances to stakeholders.
- Partners with internal and external Legal and Contracts departments on the execution of clinical trial agreements; oversee site budget templates development and budget negotiations
- Identifies and manages to key performance indicators for vendors.
- Approves and ensures adherence to study management plans, including vendor oversight, biosample management, TMF oversight, risk management, quality management, and medical/trial monitoring.
- Oversees conduct study/program-level feasibility assessments and country selection.
- Performs oversight visits of CRO monitors and clinical sites as required
- May attend KOL meetings and advisory boards
- Recruits, hires, trains, manages, and retains direct reports (i.e. CTMs/CTAs) and oversees work to ensure study deliverables are met.
- Reviews and revises SOPs, working practices as directed
- May lead or contribute to departmental process initiatives
Education and Experience
- BA/BS degree, preferably in the life sciences; advance degree preferred.
- 10+ years of experience in all phases of clinical drug development filing INDs and NDAs/BLAs, 6+ years with Masters or PhD.
- Proven ability to lead cross functional teams
- Prior line management experience preferred
- Excellent interpersonal and written communication skills
- Proven ability to successfully plan, implement, and manage multiple clinical trials for a molecule
- Prior CRO and vendor management skills is a must
- Strategic agility
- Excellent working knowledge of FDA & ICH/GCP regulations and guidelines
- Ability to travel internationally up to 25%
Please upload your cover letter and resume