Associate Director / Director, GCP Compliance
Location: South San Francisco, CA
Position type: Full-Time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company focused on discovering and developing transformative protein-based medicines for patients with serious unmet medical needs. The company has an emerging portfolio of innovative products for inflammation and cancer and currently has 3 protein therapeutics in clinical testing covering 11 indications.
- FPA008 – a monoclonal antibody targeting CSF1R in multiple disease areas including six solid tumors and pigmented villonodular synovitis (PVNS)
- FPA144 – a monoclonal antibody targeting FGFR2b for selected gastric cancers
- FP1039 – A FGF ligand trap in Phase 1b for mesothelioma
FivePrime also focuses on developing world-class diagnostic and biomarker strategies for the appropriate therapeutic settings. FivePrime’s discovery platforms can rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models leading to novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple partnerships with pharmaceutical companies including GlaxoSmithKline, UCB, and Bristol-Myers Squibb across a range of therapeutic indications. Five Prime is committed to innovation and outstanding science, values that are reflected in our people and our products.
We are seeking a motivated and ambitious individual to join the Quality team as an Associate Director/Director, GCP Compliance. This individual will provide compliance leadership and work with quality management, external auditors, in conjunction with clinical departments to ensure GCP and GLP compliance across all Five Prime projects. Additionally, the position will provide compliance oversight of pharmacovigilance activities within the organization, and be responsible for implementing clinical compliance plans to include external GCP audits of clinical service providers, CROs, suppliers, and investigator sites, as well as internal audits of trial master files, and clinical and pharmacovigilance processes and procedures. This position reports to the Vice President of Quality.
Responsibilities will include the following:
- Formulate GCP compliance strategy and provide advice for all studies and programs within FivePrime.
- Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures
- Identify and prioritize an audit strategy for all programs
- Plan and lead GCP and GLP compliance audits (international and domestic), including clinical investigator sites, contract clinical laboratories and CROs; to determine compliance status and identify compliance risks
- Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented.
- Partner with Clinical Development stakeholders, including Regulatory Affairs, Clinical Operations, Clinical Development and Pharmacovigilance/Safety, regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement; serve as an expert in the interpretation of GCP and GLP regulatory requirements and expectations.
- Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
- Play a lead role in regulatory authority inspections and the coordination of responses to resolve inspection findings.
- Facilitate GCP/GLP training of functional areas and/or develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
- Develop and implement standards, policies and procedures for GCP/GLP regulatory compliance.
- Work closely with the Chief Medical Officer to design and implement company-wide strategies
- Report and escalate compliance issues to management, including requests for directed audits and suspected scientific misconduct
- Participate in quality and compliance improvement initiatives within and outside of Clinical Development.
- Participates in the evaluation and selection of CROs and other clinical and nonclinical service providers and supports due diligence activities.
- Provide guidance, interpretation and information on GCP and GLP regulations, standards and quality systems.
- Provide input to the preparation of documents for internal reports, external partner reports and/or regulatory filings.
- BS/BA degree in scientific discipline from an accredited college or university or equivalent experience. Advanced degree preferred
- 10 years of relevant pharmaceutical industry experience with a minimum of 4 years of GCP compliance experience
- In-depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations and guidelines
- Experience in planning and conducting GCP and GLP audits
- Experience with regulatory inspections and inspection readiness (EU experience and experience with pharmacovigilance QA is a plus)
- Experience with Quality Management Systems (e.g. documentation and records management, change control, deviations, investigations, training, and CAPA programs)
- Experience reviewing and auditing study-related documentation (e.g. study reports, Investigator Brochures)
- Experience in the use of relevant computer systems used in clinical and non-clinical research including safety databases
- Familiarity with signal detection systems is a plus
- Excellent interpersonal and written communication skills
- Ability to influence and negotiate effective solutions
- Strong critical thinking and decision making skills
- Must be able to travel up to 30%
Please submit your resume.