Associate Director / Director, Drug Safety
Location: South San Francisco, CA
Position type: Full-time, Exempt
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 motivated individual to join our Drug Safety group within the Clinical Development function. The individual will work together with the Head of Drug Safety, Medical Monitor, and Study team members in managing study drug safety activities, including safety assessments of products throughout their lifecycle and oversight of global drug safety processes and other delegated safety activities. In addition, will also perform some operational activities to support the development of the department infrastructure to ensure compliance of pharmacovigilance activities with appropriate regulations and quality standards. This position reports to Senior Director, Drug Safety.
- Conduct medical review of individual case safety reports (ICSR) within workflow timelines and per ICH-GCP guidelines, regulatory requirements and company’s SOPs.
- Perform quality control review of all SAE cases to ensure medical accuracy, integrity and completeness of information reported and entered in the safety database.
- Contribute to the review, development, and reporting of drug safety information to regulatory authorities, including but not limited to individual case safety reports (ICSRs), INDs, NDAs, annual report summary statements, and Periodic or Developmental Safety Update Reports.
- Provide guidance and review of safety section(s) of study protocols, IC, forms, IB/DCSI updates, SPI, etc.
- Interact with business stakeholders, CROs, etc., for assigned products and clinical programs. Participate in meetings for different clinical programs.
- Perform routine surveillance review and evaluation of safety aggregate data as part of routine and ad-hoc signal detection activities and contribute to the development of risk management plans.
- Contribute to the development, review, and update of new Drug Safety/Pharmacovigilance SOPs, drug safety processes, Safety Data Exchange Agreements. and other safety related tasks to support the development of the department infrastructure.
- Participate in the organization and maintenance of safety information.
- Other projects when assigned.
- M.D. or Pharm.D. degree highly preferred, specialization and/or experience in oncology or hematology preferred.
- Minimum of 12+ years of safety/pharmacovigilance hands on experience in clinical and post-marketing with global product responsibility
- Excellent knowledge and understanding of FDA, EU and ICH guidelines and regulations governing clinical trials and post marketing safety
- Great knowledge of principles of clinical assessment of adverse events in the pharmaceutical industry
- Ability to evaluate and interpret medical clinical and scientific data
- Excellent clinical judgement and ability to articulate complex clinical issues in a scientifically sounds and understandable way
- Subject matter expert in performing medical review of all types of ICSRs from all report sources.
- Experience in Safety systems (either Argus or AERS, ARISg) and understanding of aggregate data is required.
- Hands-on experience with case evaluation, signal detection activities, including analyzing/categorizing/assessing data.
- Understanding of Pharmacovigilance Operational activities.
- Excellent interpersonal and written communication and ability to influence others
- Demonstrate cross-functional collaboration, ability to work effectively in a team setting to resolve issues and reach solutions
- Demonstrated ability to utilize effective critical thinking and problem-solving skills
- Expertise in MedDRA dictionary relevant to AE/SAE coding
- High attention to detail and accuracy
- Strong commitment to business ethics
Please upload your cover letter and resume