Senior Clinical Development Scientist
Gilead Sciences · Parsippany, NJ +1 more
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Role summary
Gilead Sciences seeks a Senior Clinical Development Scientist to support late-stage oncology clinical trials, including protocol development, study execution, data analysis, and regulatory submissions. The role involves collaborating with clinical leadership on CAR T-cell therapy programs and may include people management responsibilities.
What they're looking for
- PharmD or PhD in clinical research/clinical pharmacology with biopharma or drug development experience
- MS with 6+ years relevant scientific or drug development experience
- BS or RN with 8+ years relevant scientific or drug development experience
- Knowledge of FDA/EMA regulations, ICH guidelines, GCP, and clinical procedures
- Strong analytical, communication, and organizational skills with demonstrated adaptability
- Experience in Multiple Myeloma and/or CAR-T therapy preferred
- Proficiency with Microsoft Office and job-related software
What you'll be doing
- Develop study concept sheets and protocols using clinical trial design knowledge
- Participate in protocol review discussions on study design and scientific aspects
- Prepare protocols, amendments, study manuals, and investigator meeting materials
- Contribute to CRF design, data management manuals, and data analysis plans
- Support regulatory document preparation and scientific manuscript/presentation development
Privacy & handoff
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