Senior Clinical Trial Manager (Contract)
Location: South San Francisco, CA
Position type: Full time (Contract)
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 Clinical Operations group. The contract Sr. CTM leads the cross-functional study execution team (SET) and is accountable for managing the full scope of clinical trial(s) and coordinating cross-functional team and vendor efforts and ensures the clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, regulations, and ICH/GCP guidelines in accordance with the Clinical Development Plan (CDP).
- Lead cross-functional Study Execution Team(s) (SET) and vendor efforts to ensure Five Prime clinical trials are initiated efficiently and completed on time
- Provide operational expertise and partner with the SET to ensure that scientific objectives of the clinical studies are met
- Partner closely with Clinical Development Team (CDT) and other functions to design and write clinical trial protocols
- Lead the authoring and finalization of project and study related documents including IBs, informed consent forms, annual reports, and clinical study reports
- Independently draft, review and implement study management plans and vendor oversight plans. Ensure CRO, vendors, and SET adhere to study plans
- Lead the identification and selection of study CROs and vendors (e.g., CRO, IxRS, Central and Specialty labs), including negotiation of scope of work, budgets
- Provide direction and oversight of CROs and vendors to ensure delivery against scope of work. Manage vendors to key performance indicators
- Conduct study feasibility assessments; partnering with team and program lead on final country and site selection
- Lead investigator meeting planning and execution. Ensure sites, vendors and internal staff are trained on study protocol and processes.
- Work with external partners and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled, and of high quality
- Participate in the ongoing and final review of study data and assessment of the impact of this data to the study and program
- 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 and review of vendor invoices against scope of work. Partner closely with the program lead to ensure accurate accruing of study costs and forecasting of study budget. Identify and communicate variances.
- Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites
- Partner with Data Management to design and develop of eCRFs. monitoring conventions, and edit checks. Oversee data discrepancy management and vendor or site retraining as needed.
- Oversee implementation of study systems (e.g., CTMS, eTMF, eCOA, IxRS)
- Partner with Clinical Supply to forecast IMP and determine clinical trial supplies required for trial execution
- Participate in and may lead department process improvement initiatives and system implementation
- Review and provide input on cross functional SOPs, working practices and assist in the creation and improvement of department infrastructure as directed
The contract Sr. CTM is responsible for managing the day to day operational aspects of clinical trials in compliance with the applicable GCP/ICH guidelines. This contract 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/D 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/D 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)
- 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
- 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
- Agility and flexibility
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
- Highly effective verbal and written communication and presentation skills in English
- Ability to travel up to 25%
Please upload your cover letter and resume.