Senior Drug Safety Associate
Location: South San Francisco, CA
Position type: Full-time, Regular
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 and ambitious individual to support the FivePrime Drug Safety department as an interdepartmental project lead in the handling of safety data from clinical trials of FivePrime investigational products. This position will be responsible for executing the day-to-day activities for the Drug Safety group and reports to Director of Clinical Science, Drug Safety.
- Process timely SAEs reports of FivePrime investigational products in accordance with all applicable regulations, guidelines. Regulatory Authorities and cross-reporting to pharmaceutical partner(s).
- Ensure all safety information is handled in a manner consistent with departmental standard operating procedures as well as federal and international regulations.
- Liaise with Clinical Science to ensure that appropriate medical review and assessment is provided for assigned case reports
- Assist in the safety management activities for Five Prime Sponsored Clinical Trials
- Participate in development, implementation and maintenance of quality systems for all Drug Safety activities, encompassing processes, procedures, compliance and metrics.
- Participate in the preparation of aggregate safety reports such as DSUR and IND Annual Reports, to regulatory authorities
- Maintain regulatory and department compliance by ensuring timely completion of reports and facilitating submissions of reportable cases to regulatory agencies, study investigators, and licensing partners
- Assist with periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies
- Participate in cross-functional project teams representing the Drug Safety department
- Assist in monitoring industry best practices, and changes in global safety regulations and guidelines, recommend changes/ upgrades to existing departmental policies, SOPs and systems.
- Draft drug safety documents, such as Safety Management Plans for clinical studies, and development of various forms as required, such as SAE Reporting Forms, Pregnancy Reporting Forms
- Bachelor’s Degree in life sciences, e.g. pharmacy, nursing or equivalent
- Minimum of 6+ years of relevant experience which included 4 years in drug safety
- Broad knowledge of domestic and international drug safety regulations, industry practices and standards
- Working knowledge with at least one major safety database system (e.g. Argus, ARIS-g)
- Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
- Strong attention to detail, teamwork and take initiative
- Excellent written and interpersonal communication skills
- Proven ability to influence and collaborate with business stakeholders effectively and in a positive manner
- Great project management skills and ability to execute and manage multiple projects and deadlines with shifting priorities and resources in a fast-paced working environment
Please upload your cover letter and resume