Fate Therapeutics is looking for an experienced medical professional to join our Clinical Development group as a Medial Director. The successful candidate will play a key role in our autoimmunity programs and will contribute to study designs, protocol development, and data interpretation. The Medical Director will be directly involved in all aspects of study conduct, working with internal teams and the external community, building relationships with Key Opinion Leaders, investigators, and clinical sites. This is a full-time, exempt position and can be located at our corporate headquarters in San Diego, CA.
Responsibilities
Provide clinical leadership of a comprehensive and integrated Clinical Development Plan for individual autoimmune programs from first-in-human studies through registrational studies.
Contribute to study designs, lead protocol development, and collaborate with cross-functional teams in study start-up activities in partnership with clinical investigators, key opinion leaders and Health Authorities.
Direct hands-on involvement in all aspects of study conduct, in collaboration with Fate clinical development and contracted personnel, in the conduct of clinical activities including medical monitoring, data review, analysis, and reporting that conforms to the highest ethical, safety and quality standards and in compliance with Fate, GCP and regulatory standards.
Work closely with Clinical Operations to execute the clinical trial efficiently, with high quality, and within timelines.
Contribute to data activities including query generation and resolution, data cleaning, and database locking.
Remain current on the therapeutic landscape in the relevant therapeutic areas through review of the scientific literature, interactions with key opinion leaders and other external experts and attendance at relevant scientific meetings to provide input and guidance for the strategic direction of Fate programs.
May participate as clinical contributor in Fate business development and investor-related activities.
May participate in Health Authority interactions.
Review available preclinical data that could inform the design of future clinical trials.
Attend and present at investigator meetings and site initiation visits as applicable.
Actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, and other periodic clinical reports.
Collaborating with cross-functional groups formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data.
May oversee direct reports or contractors.
Qualifications
M.D., M.D./Ph.D. degree or equivalent.
Board Certification or Board Eligibility in the field of medical rheumatology required.
4+ years of experience in clinical development, including the design and execution of clinical trials, preferably within a pharmaceutical, biotech or CRO.
Experience in managing clinical programs from Phase 1 through Phase 3 is preferred.
Knowledge of autoimmune diseases such as lupus, systemic sclerosis, vasculitis, rheumatoid arthritis, or other relevant indications.
Experience or exposure to the development of adoptive cell therapies or biologic therapies is desirable.
Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable.
Willingness to engage with investigators, key opinion leaders, and external advisors, as well as effectively give presentations at conferences, advisory meetings, and other public forums.
Ability to multi-task and willingness to flexibly contribute simultaneously to multiple facets of drug development; willingness to learn new therapeutic areas.
Willingness to educate and mentor internal and external colleagues and collaborators.
Working conditions & physical requirements
Travel will be required (up to 30%).
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Compensation
The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
The anticipated salary range for this role is $270,000 - $320,000.
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.
Equal Employment Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
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About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit
www.fatetherapeutics.com.
