Senior Clinical Trial Manager
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.
We are seeking a Sr. Clinical Trial Manager (Sr. CTM) to assist the Clinical Development team in conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials.
The Sr. CTM is responsible for managing the day to day operational aspects of clinical trials in compliance with the applicable GCP/ICH guidelines. This position will report into the Associate Director of Clinical Operations.
- Manage cross-functional Study Execution Team(s) (SET) and vendor efforts to ensure Five Prime clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
- Partner with CPM/ AD to develop and implement operational strategy for assigned clinical trials including country selection, site selection, vendor selection, study timelines and budget
- Write or contribute to preparation and finalization of project and study related documents including investigator brochure, protocols, informed consent forms, case record forms, clinical study reports, and study management plans
- Partner with SET members, vendors and sites to ensure the timely delivery of high quality clinical data; coordinate and perform routine and final database lock listings review
- Participate in selection and perform ongoing service provider management and oversight of study vendors (e.g., CRO, IxRS, Central and Specialty labs), including negotiation of scope of work, budgets, performance management, risk management and issue resolution
- Provide oversight of site management through review of CRO monitoring visit reports and Key Performance Indicators
- Proactively identify and mitigate study-specific risks. Effectively communicate study status, risks, and changes that may impact quality, timelines, and cost to internal and external stakeholders
- Manage study budget. Partner closely with CPM/ AD to ensure accurate accruing of study costs and forecasting of study budget. Review vendor invoices against contract and work completed; identify and transparently communicate variances. Oversee reconciliation of site payments against patient visits to ensure accurate payments
- Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites, until execution
- Manage clinical trial supplies required for trial execution
- Assist in the training of CROs, CRAs, vendors and site staff on study protocol and processes
- Support the management and execution of study-related meetings by developing and presenting study materials (e.g., investigators, CRA training meetings)
- Proven ability to successfully plan, implement, and manage global clinical trials
- Ability to manage cross functional clinical study teams to high performance
- Proven ability to effectively manage CROs and clinical study vendors
- Ability to negotiate with vendors and teams
- Strategic thinking skills
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
- Highly effective verbal and written communication and presentation skills in English
Education and Experience
- BS/BA in Life Science or related discipline
- 5+ years of experience in clinical and drug development
- Global clinical trial and CRO management experience in oncology
Please upload your cover letter and resume