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 Squib 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.
FivePrime Therapeutics, Inc. is seeking a motivated and ambitious individual to lead the development and implementation of the regulatory strategy for a project under clinical investigation. The individual will represent Regulatory Affairs and work closely with cross-functional teams. This is a Sr. Manager/ Associate Director level role reporting to the Executive Director of Regulatory Affairs.
Responsibilities will include but not be limited to the following:
- Develop and implement strategies to facilitate the progress of Phase I through Phase III clinical development programs.
- Plan regulatory milestones over the product lifecycle in coordination with cross-functional interdependencies.
- Serve as regulatory representative for select product development programs, including regulatory liaison with business partner(s), the FDA and other regulatory agencies.
- Conduct regulatory risk assessments including risk mitigation.
- Lead cross-functional team to develop complex regulatory submissions.
- Review technical reports and summary documents (clinical, pharmacology, CMC) for adherence to regulatory guidelines, strategies, and commitments.
- Recommend regulatory policies to assure adherence to FDA requirements. Contribute to the modification, development and implementation of company practices and policies for Regulatory Affairs.
- Provide regulatory expertise and policy support; educate others on regulatory policy and environment and impact to internal organization.
- Identify and resolve issues in a timely manner.
- Manage internal personnel and activities of external contractors.
- Develop individual talent and coach others to produce results.
- Strong strategic regulatory expertise across phases of drug development
- Extensive knowledge of FDA regulations, practices and ICH guidances
- Strong knowledge of global health authority regulations and practices
- Experience leading, developing and implementing clinical and/or CMC complex regulatory strategy
- Experience in managing major regulatory filing(s) such as IND or NDA marketing applications
- Direct experience in oncology
- Experience with CMC and/or companion diagnostics a plus
- Excellent verbal, written, negotiation, influence and interpersonal communication skills
- Previous experience in leading cross-functional teams
- BA/BS degree in the life sciences; advanced degree desirable.
- ≥10 years of experience working in a regulated environment
- ≥4 years of management experience
Please upload your cover letter and resume