Clinical Scientist, Cell Therapies
Overview
Fate Therapeutics seeks a scientifically rigorous Clinical Scientist to advance innovative cell therapies from early development through regulatory approval. This scientist will serve as a key scientific partner collaborating with cross-functional teams to ensure ethical conduct and GCP compliance. The role involves designing and interpreting clinical studies and supporting regulatory submissions.
What You'll Do11
- 1Review analyze interpret emerging study data from clinical trials across the program ensuring data integrity and ethical safety standards
- 2Partner with study team to develop strategic documents such as eCRFs clinical study plans protocols and reports
- 3Contribute to regulatory document reviews including Investigators’ Brochures safety updates IND NDA submission documents and adverse event evaluations
- 4Stay current on therapeutic area standards to support program strategic decisions
- 5Support data review activities including database lock safety reconciliation and review of medical coding laboratory data and concomitant medications
- 6Develop relationships with investigators to optimize clinical study design execution reporting and publications
- 7Coordinate real time availability of quality clinical trial data for senior management meetings
- 8Assist in forecasting trial resource needs both internal and external
- 9Design and conduct oncology or autoimmune clinical trials with experience in novel combinations and innovative designs
- 10Write and present scientific communications with clarity accuracy and rigor
- 11Collaborate with internal and external study teams to provide consolidated information for advisory boards safety monitoring and study team training
Requirements12
- 15+ years building ETL pipelines with Spark and Airflow
- 2MS RN PhD or PharmD with minimum 3 years technical and/or operational experience in planning executing reporting and publishing clinical studies
- 3Experience in the design and conduct of oncology or autoimmune clinical trials
- 4Experience with novel combinations and innovative designs for early phase studies
- 5Proven ability to write and present scientific communications with clarity accuracy and rigor
- 6Experience with U.S. and European regulatory authorities and submissions
- 7Exposure to cell therapy development
- 8Self-motivation good judgment strong follow up organizational analytical and problem solving skills
- 9Ability to work with lead and motivate cross functional matrix team
- 10Excellent written and oral communication skills
- 11Working conditions include travel up to 10% extended sitting standing vision monitor moderate noise
- 12Competitive compensation including bonus equity and benefits package
Salary Insight
$130 - $150k per year
Location
Required Skills
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