Executive Director, Clinical Development
New
C
Centessa Pharmaceuticals, LLCBiotech Pharmaceuticals
The Executive Director, Clinical Development role is based in the USFull-TimeDirector
Salary$300,000 to $375,000
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Job Details
- Experience
- Minimum 10 years of combined professional experience; Minimum 5 years of pharma or biotech industry experience
Requirements
- MD in neurology/neuroscience; board certification required.
- Minimum 10 years of professional experience in CNS therapeutic areas across academia, clinical practice, or industry.
- Minimum 5 years of pharma or biotech industry experience with leadership in clinical development and global clinical trials.
- Direct experience in sleep disorders therapeutic areas.
- Proven people and line management experience.
- Excellent knowledge of FDA, EMA, and other regulatory agency guidelines.
- Proficiency with GCP and ICH guidelines.
- Experience leading and authoring clinical inputs for regulatory submissions (IND, NDA/BLAs).
- Strong ability to analyze and interpret translational medicine and clinical research data.
- Willingness to travel as required.
Responsibilities
- Serve as a senior clinical leader for Program 750, providing medical and scientific leadership for late-stage development.
- Author and oversee clinical study protocols for orexin receptor agonists to ensure scientific rigor and regulatory alignment.
- Develop integrated clinical development plans (CDPs) spanning preclinical through late-stage trials.
- Collaborate with Clinical Operations to manage quality, timelines, and budgets for CNS clinical programs.
- Provide medical guidance for ongoing trials including data review, safety oversight, and biomarker strategy.
- Engage with investigators, KOLs, and external experts to advance scientific innovation.
- Author and review clinical sections of regulatory submissions such as INDs, protocol amendments, and clinical study reports.
- Ensure robust safety monitoring and adherence to Good Clinical Practice (GCP) and pharmacovigilance standards.
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