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About the Role

Fate Therapeutics is seeking a scientifically rigorous and highly motivated Clinical Scientist to join our Clinical Development team. The Clinical Scientist will play a key role in advancing our pipeline of innovative cell therapies from early clinical development through regulatory approval. This role supports the design, execution, and interpretation of clinical studies while ensuring ethical conduct, patient safety, and GCP compliance. The Clinical Scientist will collaborate closely with cross-functional teams to advance clinical programs.

Responsibilities

Review, analyze, and interpret emerging study data from clinical trials, ensuring data integrity, ethical standards, safety, and regulatory compliance.
Partner with the study team to develop key strategic documents, including eCRFs, clinical study plans, protocols, and reports.
Contribute to the review and presentation of clinical sections of regulatory documents, including Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, study protocols, informed consents, statistical analysis plans, regulatory approval submissions, adverse event evaluation, and responses to Health Authorities inquiries.
Stay current on standards of practice within relevant therapeutic areas to support strategic discussion and decision-making.
Support data review activities including ongoing data cleaning through database lock, ensuring safety and response data reconciliation, review of medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends, and review of data tables, listings, figures, and clinical study reports.
Develop effective working relationships with key investigators and coordinators to optimize scientific quality and innovation of clinical study design, execution, reporting, and publications.
Support contributions to meetings for trial-related advisory boards, investigators, safety monitoring, and study team training.
Coordinate with internal and external study teams for 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).

Requirements

MD, MS, RN, PhD, or PharmD with a minimum of 6 years of technical and/or operational experience in planning, executing, reporting, and publishing clinical studies in a biotech, pharmaceutical, or CRO environment.
3+ 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 and presenting scientific communications with clarity, accuracy, and rigor.
Experience with U.S. and European regulatory authorities and submissions is desirable.
Experience or exposure to the development of cell therapies is desirable.
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 with cross-functional teams and through formal presentation and scientific discussion ensuring credibility, accuracy, and confidence with internal and external stakeholders and experts.

Skills

Cell therapies
Oncology
Autoimmune
Clinical study design
Clinical study execution
Clinical study reporting
Clinical study publications
Scientific communications
Regulatory submissions
Data integrity
Patient safety
GCP compliance
Cross-functional team collaboration
Problem-solving
Analytical skills
Organizational skills
Written communication
Oral communication

Location

San Diego, CA

Work Type

Full-time
Exempt

Experience Level

Minimum 6 years technical and/or operational experience
3+ 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
Experience with U.S. and European regulatory authorities and submissions is desirable
Experience or exposure to the development of cell therapies is desirable

Education Level

MD
MS
RN
PhD
PharmD

Salary/Compensations

$130,000 - $143,000

Benefits

Annual bonus
Equity
Generous benefits package

About the Company

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA.

Equal Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.