Executive Director, Clinical Development
New
M
Mineralys TherapeuticsBiopharmaceutical
US RemoteFull-TimeDirector
Salary$340,000 - $370,000
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Job Details
- Experience
- 10+ years
- 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 a 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.
- Experience in hypertension, cardiovascular, renal, or metabolic disease strongly preferred.
- Strong scientific communication and presentation skills.
Responsibilities
- Serve as the clinical lead for one or more clinical programs, managing trial design, execution, and milestone delivery.
- Develop clinical plans, protocols, and study-related documentation.
- Provide medical oversight for Phase 2/3 and registrational studies to ensure patient safety and data integrity.
- Partner with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory to drive execution.
- Act as medical monitor for assigned studies, conducting safety surveillance and benefit-risk assessments.
- Contribute to global regulatory strategy and author clinical sections of regulatory submissions.
- Present clinical data and strategy to health authorities and senior leadership.
- Collaborate with internal teams and KOLs to align development strategy with launch needs.
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