Director / Senior Director, Pathology
Location: South San Francisco, CA
Position type: Full-time, Exempt
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime's comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company's R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.
We are looking for a talented Director/Senior Director to lead pathology efforts that focus on development of FivePrime’s pipeline of preclinical and clinical therapeutics and antibodies in immuno-oncology and other disease settings. This individual will provide leadership and strategic coordination across cross functional teams and with vendors. S/he will interpret and present data to project teams and senior management to enable effective decision making aimed at optimizing patient selection strategies through biomarker analysis.
This individual will be a key leader in Development Sciences and be part of a matrixed organization that serves research, preclinical and clinical stage programs. A strong track record demonstrating leadership and success in pathology support for development-stage drugs and for support of clinical trials is required. This position reports to Executive Director, Asset Team Lead.
- Serve as a leader in Development Sciences, representing pathology functions across FivePrime’s matrixed organization
- Represent pathology functions on multiple project teams in Preclinical and Clinical Development
- Select, manage and oversee vendors to support pathology for preclinical and clinical programs.
- Oversee or play the central role in the interpretation of data, such as validating antibodies for IHC, reading slides, and implementing scoring systems
- Manage scientists and research associates who develop and carry out various protocols to validate antibodies for staining and other assays
- Author and approve study protocols and reports
- Author appropriate sections of regulatory documents (INDs, CTA, BLAs)
- Coach and mentor scientists and associate-level employee to execute pathology and corporate goals.
Education and Experience:
- MD or DVM with board certification in pathology with extensive application to tumor biology.
- 10 years of pharmaceutical and/or biotech industry experience
- Deep knowledge of both human and mouse pathology
- Ability to perform macroscopic and microscopic evaluation of tissues and immune-infiltrates derived from preclinical and clinical studies is required
- Proven track record of developing scoring algorithms for IHC used in clinical trials.
- Direct experience with IND filing and documentation.
- Knowledge of FDA approval process for companion diagnostics.
- Proven record of ability to identify, audit, and interpret clinical data from CRO’s involved in development of companion diagnostics or analysis of biomarkers from clinical specimens.
- Extensive expertise in tumor immunology is highly desirable.
- Experience with strategic interpretation of biomarkers between human cancer and mouse tumor models is highly desirable.
- Experience in the early identification and development of biomarkers and multiplex IHC is a plus
- Proven experience leading a pathology program in a biotech company is essential
- Prior managerial experience or cross functional management of PhD level scientists is desirable
- Very strong leadership, influencing, and inter-personal skills
- Excellent written and oral communication skills
- Ability to lead and work with others in a positive and collaborative manner.
Please upload your cover letter & resume.