Clinical Trial Manager II
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 individual to join the Five Prime Therapeutics Inc. Clinical Operations group. This individual will play a key role in assisting the Clinical Development team in conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. This position will support the management of clinical operations activities and coordinate cross functional efforts in the implementation and conduct of a clinical trial(s) to achieve trial objectives and corporate goals. This position reports into the molecule Program Lead.
- Lead defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
- Serve as a member of one or more Clinical Operations study management teams (SMT) and as a member of the cross functional study execution team (SET). May lead a SET as required by the needs of the project
- Participate in CRO and vendor selection; develops RFPs for study vendors, review proposals and make CRO and vendor selection recommendations in collaboration with the SET
- Day-to-day management of assigned vendors to ensure that project goals are achieved; organize and lead teleconferences with key vendor personnel, facilitate vendor activities and oversee adherence to scope of work and service agreement
- Participate in developing and finalizing cross-functional SET deliverables such as clinical study protocols, CRFs, consent forms, study reference manuals, study reports, annual reports and other clinical documents
- Study budget management; review invoices for assigned vendors, identify and communicate accruals and variances, provide input to study budget forecast
- Conduct site feasibility and partner with SET and CRO to identify and select clinical trial sites
- Partner with Contracts department on the development of site budget and clinical trial agreement (CTA) templates and on the negotiations with clinical sites. Ensure site payments are accurate and reconciled against patient visits.
- Perform oversight and/or co-monitoring visits of clinical sites, as required
- Review CRO monitoring reports and ensure completion of action items. Identify trends and risks. Escalate unresolved issues.
- Partner with SET, vendors, and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled
- Participate in routine and final data listings review
- Participate in implementation and oversight of study systems (e.g., CTMS, eTMF, or IxRS)
- Create and implement assigned study management plans, (e.g. monitoring, vendor oversight, TMF oversight)
- Ensure that supportive study supplies and documents are available (e.g., contracts, IxRS, lab kits, non-clinical supply materials)
- Create, maintain and conduct ongoing quality review of the TMF to ensure files are properly maintained and up to date, archived and stored
- Track key study metrics, track study activities and create study-specific tracking tools
- Plan investigator meetings and develop content and/or site training materials
- Proactively identify issues and risks and propose mitigation
- Assist with planning investigator meetings and developing content and/or site training materials
- Assist with training vendors and team members on study protocol and processes
- Attend SET meetings, develop agendas, take and distribute meeting minutes
- Participate in department process improvement initiatives and system implementation, review and provide input on working practices, SOPs and departmental infrastructure
- BS/BA in Life Science or related discipline
- 4+ years industry experience in clinical drug development
- Effective team player and ability to influence and collaborate with cross functional clinical study teams
- Effective written and interpersonal communication skills
- Ability to manage delegated aspects of assigned clinical trials
- Ability to independently manage assigned clinical study vendors
- Ability to proactively identify and mitigate study risks.
- Strong planning and organizational skills
- Working knowledge of FDA & ICH/GCP regulations and guidelines
- Ability to travel internationally up to 25%
Please upload your cover letter and resume.