Director, Clinical Biomarkers & CDx Development, Biomarker Biology and Translation
Location: South San Francisco, CA
Position type: Full-time
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 join our Clinical Biomarkers and CDx Development group. This position will oversee a group whose primary focus is the development and integration of biomarker biology and strategy across preclinical and clinical development. This individual will provide leadership and coordination of a group of scientists to include biologists, pathologists and other scientists whose focus is development and implementation of biomarker biology and patient selection strategies for FivePrime’s pipeline of protein-based therapeutics. The Director of Biomarker Biology and Translation will be part of a matrix organization that serves research, preclinical and clinical stage programs. This position reports to Executive Director of Clinical Biomarkers and CDx Development.
- Provide leadership and “hands on” direction to a core group that will work to develop and integrate biomarker biology and diagnostics into FivePrime’s Research and Development pipeline.
- Interface with Discovery Research, Preclinical Development, Bioanalytical and Clinical groups at FivePrime to identify strategies for the development of pharmacodynamic and patient selection biomarkers for FivePrime’s therapeutics.
- Ensure effective cross-functional interactions between the different functional groups as relates to biomarker and diagnostic discovery and development
- Oversee assay development and interpretation for the development of cutting-edge biomarker or companion diagnostic development
- Mentor and coach scientists and research associates who design, perform or interpret assays to interrogate key biomarkers.
- Utilize multiple biomarker technologies and resources to enable strategic vision and support of clinical development programs and to ensure state of the art thinking on appropriate biomarker technologies
- Participate as a key member of multi-disciplinary project teams providing expertise on biomarker utility and applications.
- Identify and liaise with key opinion leaders in the area of clinical biomarkers to guide the project team to select and utilize appropriate biomarker strategies. Work closely with project team or sub-team members to plan and implement sample handling and analysis in clinical studies.
- Follow scientific trends in the area of biomarkers and their utilization as response markers and diagnostics as applied to targeted therapies directed in the fields of oncology, inflammation and immune-oncology.
- Ph.D. degree in an appropriate discipline required
- Minimum of 10 years of relevant experience working in the area of drug development, with at least 5 years in a leadership position
- Prior experience working in the field of translational medicine, biomarker biology or companion diagnostics is essential
- Experience in approaches to development and translation of biomarkers, novel assay development and data interpretation is required as demonstrated by a track record of publications in high-impact journals
- Experience with strategic interpretation of biomarkers between human cancer and mouse tumor models is highly desirable
- Deep knowledge of both human and mouse biology in health and disease is desirable
- Extensive expertise in tumor immunology is highly desirable
- Ability to influence cross-functionally in a positive and collaborative manner
- Effective leadership that can lead by example
- Think strategically and add value by bringing unique insight to team
- Excellent written and interpersonal communication skills
Please upload your cover letter and resume