Remote Executive Director, Clinical Development

Visa Hunt; United States; On-site; USD 340,000 - 370,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

401K

Incentive plans

Job summary

Mineralys Therapeutics is a fully remote biopharmaceutical company focused on hypertension and related comorbidities. The Executive Director, Clinical Development will lead clinical development programs, provide medical and scientific oversight, and drive regulatory strategy from protocol design to launch readiness.

The role requires a hands-on leader who thrives in a fast-paced biotech environment and partners cross-functionally to deliver high-quality execution with urgency.

Qualifications

• 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.
• Experience as medical monitor and clinical lead for Phase 2/3 studies.
• Proven 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.

Responsibilities

• Serve as the clinical lead for one or more clinical programs and oversee milestones.
• Lead development of clinical plans, protocols, amendments, and study documents.
• Provide medical oversight for Phase 2/3 and registrational studies, ensuring safety and data integrity.
• Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety for execution.
• Drive study start-up, enrollment, interim analyses, database locks, topline results, and CSR delivery.
• Serve as medical monitor for assigned studies, review eligibility, safety signals, and SAEs/AEs.
• Support regulatory strategies and interactions with health authorities.
• Present data to regulators, governance committees, and senior leadership.
• Lead cross-functional teams and influence without direct authority.

Skills

Clinical leadership

Medical communications

Cross-functional collaboration

Regulatory strategy

Medical monitoring

Phase 2/3 experience

Regulatory interactions

Education

MD or equivalent medical degree

Board certification preferred (Internal Medicine / Cardiology / Nephrology / Endocrinology)

Job description

Mineralys Therapeutics is a fully remote biopharmaceutical company focused on hypertension and related comorbidities. The Executive Director, Clinical Development will lead clinical development programs, provide medical and scientific oversight, and drive regulatory strategy from protocol design to launch readiness.

The role requires a hands-on leader who thrives in a fast-paced biotech environment and partners cross-functionally to deliver high-quality execution with urgency.