Director, Clinical Science

Fate Therapeutics is looking for a Director of Clinical Science with experience in autoimmunity or oncology to join our Clinical Development team. The Director, Clinical Science will contribute to strategic and regulatory documents and will work with other departments including Clinical Operations, Biometrics, Patient Safety, and Regulatory Affairs to ensure that the company’s lead clinical trial is executed effectively and with the highest quality standards. This is a key position that will lead the review, analysis and interpretation of complex clinical data. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

• Work with Medical Director(s) to create key strategic documents including clinical development plans, clinical protocols and synopses for assigned products, amendments, and other study-related documents.
• Work closely with Clinical Operations to execute the clinical trial efficiently, with high quality, and within timelines.
• Oversee operational aspects of clinical trials including protocol development, investigator recruitment, patient enrollment, study specific guidelines and processes, and quality of data collection.  
• Contribute to the development of clinical sections of regulatory documents including Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, informed consents, eCRFs, statistical analysis plans, regulatory approval submissions, serious and non-serious adverse event evaluation, and supporting responses to Health Authorities questions.
• Perform ongoing review, analysis, and interpretation of clinical data from individual studies, and translate study level clinical data across the program of studies for assigned compounds, ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.
• Maintain a strong grasp of standards of practice in the relevant therapeutic areas to contribute to strategic discussion and decision-making for the program.
• Contribute to data activities including query generation/resolution, data cleaning, and database locking; review of safety fields for reconciliation, working with data group to reconcile SAE events as needed; review of medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends; review of data tables, listings, and figures; write and review portions of final clinical study report.
• Provide internal safety monitoring for clinical trials in collaboration with the Study Medical Director and Drug Safety team.
• Develop effective working relationship with investigators to optimize scientific quality/ innovation of clinical study design, execution, reporting, and publication.
• Contribute to trial-related advisory boards, investigators meetings, DMC and protocol training meetings.
• Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for Senior Management.
• Assist in forecasting trial resource needs (internal and external).
• May participate as a standing member of multidiscipline Project Teams. 

• MD, MS, RN, PhD, or PharmD with a minimum of 10 years of relevant and progressive work experience in planning, executing, reporting, and publishing clinical studies in a biotech, pharmaceutical, or CRO environment.
• 2 years of experience in the design and conduct of oncology or autoimmune clinical trials is desirable.
• Experience in novel combinations and innovative designs for early phase studies.
• Proven experience writing scientific communications with clarity, accuracy, and rigor.
• Experience with U.S. and European regulatory authorities and submissions is desirable.
• Experience in the development of cell therapies is a plus.
• Self-motivation, good judgment, strong follow up, organizational, analytical, and problem-solving skills; capable of identifying risks; creative and innovative thinker.
• Ability to work with, lead, and motivate a cross-functional matrix team.
• Excellent written and oral communication skills. Ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts.

• Travel may be required.
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. 

• 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 $225,000 - $250,000.

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.

Salary : $225,000 - $250,000