Senior Director / Director, Clinical Translation

Location
San Diego, CA, United States
Posted
Oct 10, 2020
Ref
384SC
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Fate Therapeutics is seeking an experienced clinical translation Physician / Scientist with scientific and clinical expertise in hematology / oncology to develop and drive innovative healthcare approaches and opportunities across Fate's clinical programs. This role will lead clinical biomarker discovery providing guidance and direction in the conceptualization, development, and implementation of translational biomarker strategies for current and future clinical programs for relevant diseases and programs. The successful candidate will have extensive knowledge and experience in integrating translational research and clinical development and development of biomarker strategy in alignment with clinical development objectives. This role will collaborate with the lab-based biomarker measurements team and will oversee integration, interpretation, and communication of data to relevant functional groups. The successful candidate will be responsible for understanding external research environments, ability to partner with discovery biology and other teams both internally and externally to execute the clinical translation deliverables. This role
will also engage functional groups across the organization to develop, champion, implement and align biomarker strategies for development projects in support of the overall R&D portfolio goals. This is a full-time position located at our corporate headquarters in San Diego, CA reporting to the Senior Vice President, Clinical Translation.

Responsibilities
• Responsible for translating preclinical hypothesis into clinical biomarker strategies for one or more projects from a broad portfolio of cell assets Phase 1/2 clinical trials
• Lead a cross-functional project team defining biomarker testing plans and translating
scientific discoveries into clinical strategies (predictive/pharmacodynamic/resistance biomarkers, molecular response endpoints, indication selection and combination strategies)
• Provide scientific leadership to peers in assigned project teams including discovery scientists, clinical researchers, bioinformatics scientists
• Prepare and present abstracts and scientific presentations at key conferences
• Identify biomarker assays for clinical implementation, including the discovery and validation of PK and PD biomarkers
• Translate biology insights into plans to support clinical development and product enhancement
• Provide expertise on translational oncology to support the writing and review of clinical and
regulatory documents
• Build and maintain strong relationships and collaborations with key scientific and medical experts to incorporate external insights and maximize the generation of scientifically robust data to accelerate our drug development programs

Qualifications
• MD / PhD or equivalent advanced degree in a relevant scientific field (i.e. immunology,
cancer biology, hematology/oncology, molecular biology, etc.)
• Minimum 5 years of experience in immuno-oncology drug development process; focus on hematologic malignancies and experience with cellular therapies preferred
• Work experience demonstrating a thorough understanding of clinical trials and clinical strategy, experience with oncology drug development as well as analytical and clinical validation of biomarker assays
• First-hand experience with identification and validation of pharmacodynamic and patient
selection biomarkers and clinical implementation
• Strong track record of vendor management to implement biomarker strategies
• Ability to partner with clinical team, pharmacology and biomarker measurements team to implement assays to track the PK/PD and relevant translational endpoints GLP and clinical
studies
• Ability to work with large, multi-omic data sets and familiar with techniques for exploring associations of biomarkers with clinical outcomes
• Computational skills with statistical software packages such as R are preferred, but not essential; experience with high dimensional data is a plus
• Excellent oral and written communication skills, and ability to generate high quality data
presentations and figures for publication in high quality scientific, technical or medical journals and for presentation at internal and external meetings
• Excellent people management skills with the ability to influence across the organization.
• Lead and thrive in an interactive, team-oriented culture

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: careers@fatetherapeutics.com and
reference job 384SC.

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.