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. The purpose of this position is to establish a new group whose primary purpose is to explore and integrate clinical trial observations with the goal of finding new biomarkers and evidence that provide insight into disease, response to therapies and enhanced strategies for clinical trials and subsequent clinical applications. This individual will provide leadership and strategic coordination of a group of scientists including biologists, pathologists and research associates whose focus is the integration of biomarker intelligence gained from current trials, the development of standardized testing and the evaluation of the latest technologies to support biomarker biology and patient selection strategies for FivePrime’s pipeline of protein-based therapeutics. The Director of Biomarker Intelligence and Testing 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 the vision and leadership to build a core group that will work to develop and integrate biomarker intelligence collected from ongoing clinical trials 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.
- Oversee the operations of a molecular histopathology core facility that may include technologies incorporating automated IHC, ISH, multiplex IHC, FACS, NGS and PCR.
- Ensure effective cross-functional interactions between the different functional groups as relates to biomarker and diagnostic discovery and development
- Oversee technology selection, assay development and interpretation for the development of cutting-edge biomarker or companion diagnostic development
- Perform evaluations of novel technologies to be potentially used for the characterization of biomarkers and subsequent interrogation of markers in a clinical setting.
- Mentor and coach scientists and research associates who design, perform or interpret assays
- 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.
- Identify and liaise with key opinion leaders in the area of clinical biomarkers and diagnostic technology to guide the project team to select and utilize appropriate 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 companion 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 strategic approaches to development of biomarkers, novel assay development and data interpretation is essential
- Experience with companion diagnostic development is required
- Experience with integration and use of diagnostic technologies in a preclinical and clinical environment is essential.
- Experience with automated IHC, NGS, PCR and ISH is essential.
- Experience with strategic interpretation of biomarkers between human cancer and mouse tumor models is highly desirable
- Experience with CAP and CLIA guidance documents and regulations for testing 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
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