Note: The job is a remote job and is open to candidates in USA. Confidential is an emerging biopharmaceutical company seeking an experienced Clinical Development Scientist/Lead to support early clinical development strategy for a rare disease program. This consultant will partner with research and cross-functional teams to prepare for an upcoming FDA Pre-IND meeting and develop early-phase clinical strategies.
Responsibilities
- Support clinical development strategy for an early-stage development program
- Prepare briefing materials for FDA Pre-IND interactions
- Design Phase 1 and Phase 2 clinical trial concepts, including objectives, endpoints, and study design
- Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs
- Interpret regulatory feedback and incorporate it into clinical development plans
- Provide strategic scientific guidance throughout early clinical development
Skills
- Experience supporting FDA Pre-IND meetings or similar regulatory interactions
- Strong understanding of IND-enabling and early clinical development
- Experience designing Phase 1 and/or Phase 2 clinical trials
- Knowledge of FDA regulations, ICH guidelines, and Good Clinical Practice (GCP)
- Excellent communication and cross-functional collaboration skills
- Ability to work independently in a fast-paced biotech environment
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