Director, Clinical Quality Assurance
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases.
We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology.
Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
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.
Reporting to Head of Quality, we are seeking a motivated and ambitious individual to join the Quality team as Director, Clinical Quality Assurance. This individual will provide compliance leadership and work with quality management, external auditors, in conjunction with clinical development departments to ensure GCP 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, including external GCP audits of clinical service providers, CROs, suppliers, and investigator sites, and internal audits of trial master files, and clinical and pharmacovigilance processes and procedures.
- Serve as the subject matter expert in GCP, develop standards and promote collaboration with Clinical Development and CRO to design and implement risk-based GCP quality systems and processes.
- Formulate GCP compliance strategy and provide advice for all FivePrime studies and programs.
- Develop and implement audit strategies for each clinical program assigned.
- Plan and manage 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. Conduct a portion of such audits.
- Manage the preparation of audit reports and report audit findings to management with recommendations for resolution. 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.
- 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 interact with agencies on GCP related matters and the coordination of responses to resolve inspection findings.
- Develop and facilitate GCP/GLP training for functional areas and personnel involved in the execution of clinical trials and nonclinical studies.
- Participate in quality and compliance improvement initiatives within and outside of Clinical Development.
- Participate in the evaluation, qualification and selection of CROs and other clinical and nonclinical service providers and support due diligence activities.
- Serve as an expert and provide guidance on and interpretation of GCP and GLP regulations, standards and quality systems.
- BS/BA degree in a scientific discipline from an accredited college or university or equivalent experience. Advanced degree preferred
- 12 years of relevant pharmaceutical industry experience with a minimum of 6 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%
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime. Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.