Executive Director, Clinical Development

The role

The Executive Director, Clinical Development will serve as the clinical lead for development programs. This physician leader provides medical and scientific oversight from protocol design through regulatory interactions and launch preparation.

What you will do

• Serve as the clinical lead for one or more clinical programs
• Lead development of clinical plans, protocols, amendments, and related study documents
• Provide medical oversight for Phase 2/3 and/or registrational studies
• Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety
• Drive study start-up, enrollment, interim analyses, database locks, topline results, and CSR delivery
• Serve as medical monitor for assigned studies
• Collaborate with Pharmacovigilance on safety surveillance, signal detection, DSMB materials, and aggregate safety reporting
• Contribute to global regulatory strategy and interactions with health authorities
• Author and review clinical sections of regulatory documents
• Present clinical data and strategy to regulators, internal governance committees, and senior leadership

Required qualifications

• MD or equivalent medical degree
• 10+ years of industry clinical development experience
• 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

Nice to have

• Board certification in Internal Medicine, Cardiology, Nephrology, Endocrinology, or related field
• Experience in hypertension, cardiovascular, renal, or metabolic disease

Benefits

• medical
• dental
• vision
• time off
• 401K
• participating in Mineralys incentive plans contingent on achievement of personal and company performance

About the company

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. It is headquartered in Radnor, Pennsylvania.