Senior Director / Director, Translational Science
Fate Therapeutics is seeking an experienced Scientist/Physician with scientific and/or clinical expertise in hematology/oncology to develop and drive innovative translational science strategy to guide clinical translation and lead translational science team members in the execution of biomarker programs. This role will be responsible for development and operational implementation of quantitative immune-based strategies to support both early and late stage drug development in oncology, leading cross-functional project teams translating scientific discoveries into clinical strategies including predictive/pharmacodynamic/resistance biomarkers, molecular response endpoints, indication selection and combination strategies. The successful candidate requires in-depth knowledge of clinical assay development and validation approaches and applications in drug development, ability to conduct detailed literature and technology reviews, successful collaboration with experts in multiple cancer disease indications, understanding of logistical and regulatory factors pertaining to clinical technologies, and partnering in close collaboration with R&D, clinical development, and clinical translation team members. This is a full-time position located at our corporate headquarters in San Diego, CA reporting to the Vice President, Research Oncology.
• Lead biomarker discovery and qualify new biomarkers and approaches for expediting proof-of-
concept for new drug candidates, including target identification, indication selection, early indication of biological activity and patient stratification / selection.
• Provide strategic leadership, influence cross-functional teams and the broader organization to prioritize and execute a compelling translational biomarker vision in oncology.
• Collaborate with R&D and product development teams to facilitate appropriate incorporation of biomarker strategies for candidates in discovery phases, leading to candidate selection and development in R&D.
• Collaborate with internal R&D colleagues to develop plan for validation and application of research assays.
• Collaborate with clinical operations and clinical translation team to implement exploratory sample collection and analyses in clinical studies related to oncology.
• Manage internal and external research collaborations in areas of clinical technologies and oncology translational research.
• Ensure complex clinical assays are fit-for-purpose, whether developed and validated internally or externally.
• Ensure timely delivery of results consistent with program team and senior management.
• Contribute to and ensure the quality of translational biomarker technical reports, study memos
and clinical study reports, data reviews and interpretations, scientific publications and recommendations to development teams and management.
• Contribute to and review documents pertaining to regulatory interactions and filings related to translational biomarkers, including product labeling and participate in internal and external meetings.
• Supervise and develop translational science team.
• PhD / MD and minimum 8 years of relevant biotech or pharmaceutical industry translational
• Proven record of oncology drug development.
• Extensive experience in translational or clinical research related to biomarkers,
pharmacogenetics, imaging, and other clinical technologies, with an extensive understanding of the technical, clinical, regulatory, and strategic aspects of these areas.
• Experience working with large, multi-Omics/FlowJo/Cytobank data sets and familiar with techniques for exploring associations of biomarkers with clinical outcomes.
• Prior experience or familiarity with IND preparation and filing preferred.
• Prior experience working with clinical trial sites and related clinical CROs preferred.
• Demonstrated record of cutting-edge research as evidenced by first or senior authored
publications in top tier journals.
• Ability to distill complex issues and clearly articulate solutions.
• Extensive experience influencing, motivating, and collaborating up, down, and across
• Extensive experience leading, supervising and developing direct reports.
• Ability to drive, lead, manage, execute and deliver results for complex multi-functional projects.
• Excellent communication and presentation skills.
Working Conditions and Physical Requirements
• 100% on-site work at corporate headquarters in San Diego, CA
• Occasional travel to meetings and conferences as required
• Occasional evening and weekend work will be required
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and curriculum vitae to: email@example.com and reference job 344CN.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.