Executive Director, Clinical Development
United StatesFull-TimeDirector
Salary340,000 - 370,000 USD per year
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Job Details
- Experience
- 10+ years of industry clinical development experience
- Required Skills
- GCP
Requirements
- MD or equivalent medical degree required.
- Board certification preferred in Internal Medicine, Cardiology, Nephrology, Endocrinology, or related field.
- 10+ years of industry clinical development experience, including significant late-stage / registrational trial leadership.
- Prior experience serving as medical monitor and clinical lead for Phase 2/3 studies.
- Proven experience with NDA / BLA submission support and health authority interactions.
- Strong understanding of GCP, ICH guidelines, safety reporting, and global clinical development processes.
- Demonstrated ability to lead cross-functional teams and influence without direct authority.
- Strong scientific communication and presentation skills.
- Experience in hypertension, cardiovascular, renal, or metabolic disease strongly preferred.
Responsibilities
- Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones.
- Lead development of clinical plans, protocols, amendments, and related study documents.
- Provide medical oversight for Phase 2/3 and/or registrational studies, ensuring patient safety, data integrity, and operational excellence.
- Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety to ensure efficient study execution and timely issue resolution.
- Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments.
- Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.).
- Author and review clinical sections of regulatory documents, including briefing books, protocols, CSRs, IBs, and submission modules.
- Serve as the key clinical voice on cross-functional program teams.
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