Vice President of Clinical Development

Job Summary

A company is looking for a Vice President of Clinical Development.

Key Responsibilities

• Serve as lead clinical expert for the Phase 3 FTD program, driving clinical strategies and regulatory activities
• Lead strategic engagement with the US FDA, including key meetings and regulatory submissions
• Own the clinical development plan from late-stage study execution through potential BLA filing and NDA approval

Required Qualifications

• MD or MD/PhD with at least 10 years of clinical drug development experience
• Proven track record in leading programs in rare diseases, CNS, or neurodegenerative disease
• Experience in bringing therapies through late-stage development and FDA interactions
• Ability to work independently and collaboratively in fast-paced environments
• Active user of large language models (LLMs) with an interest in AI applications in clinical development