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.
Five Prime Therapeutics, Inc. is seeking a motivated, proactive and ambitious leader to provide strategic leadership and direction for the Drug Safety function at FivePrime. This position reports to the Chief Medical Officer.
- Provide strategic drug safety direction to Clinical Operations and CROs to execute the programs (review safety monitoring plans, ICF safety language, etc.).
- Provide guidance and review safety section(s) of protocols, informed consent forms, statistical analysis plans, and clinical study reports.
- Represent the medical (clinical) function on one or more clinical study teams.
- Support new IND filing activities.
- Represent the Drug Safety department in DSC, SET and similar governance meetings.
- Provide strategic guidance and direction for the development, enhancement, and implementation of global safety systems initiatives to ensure regulatory compliance for AEs reporting and analysis.
- Provide strategic guidance on the planning and preparation of the adverse events section of protocols for FivePrime clinical studies.
- Allocate, administer, and direct resources within department to ensure all safety reports are processed and reported according to industry guidelines and external requirements.
- Oversee and establish appropriate metrics to ensure proper quality and timeliness of all safety management activities.
- Provide guidance on regulations and their impact on Safety management processes and procedures.
- Ensure that all safety reports received from clinical source are processed and reported according to ICH-GCP guidelines, regulatory requirements and our SOPs.
- Perform quality control review of all cases to ensure accuracy, integrity and completeness of information entered in the CRO safety database.
- Provide ongoing evaluation and guidance to ensure that our safety handling processes are efficient and scalable for future company growth.
- Monitor industry’s best practices and changes in global safety regulations.
- Other projects when assigned.
- M.D. highly preferred, will consider strong candidates with alternate medical experiences. Specialization and/or experience in oncology or hematology preferred.
- Minimum of 15+ years industry experience or equivalent experience in the management and execution of phase I-III trials.
- Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing clinical trial safety environment
- Extensive knowledge of principles of clinical assessment of adverse events in the pharmaceutical industry
- Expertise in MedDRA dictionary with relevance to adverse event coding
- Experience in working with software based drug safety systems, preferably the ARISg safety database (or AERS, Argus, etc.)
- Expert knowledge of domestic and international safety regulations, Good Clinical Practices, principles of drug development and safety assessment of marketed and investigational drugs.
- Excellent clinical judgment and ability to articulate complex clinical issues in a scientifically sound and understandable way
- Excellent written and interpersonal communication skills
- Ability to work effectively cross-functionally and in a highly collaborative environment
Please upload your cover letter and resume