Executive Director, Clinical Development

Mineralys Therapeutics, Inc.; United States; On-site; USD 250,000 - 360,000; Full time

Job summary

Mineralys seeks an Executive Director of Clinical Development to lead our hypertension-focused programs and related metabolic conditions. The role entails senior medical oversight of Phase 2/3 and registrational studies, with direct collaboration across Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety teams.

Ideal candidates bring MD-level credentials with 10+ years in industry, proven leadership in late-stage trials, and strong NDA/BLA experience, plus a track record

Qualifications

• MD or equivalent with 10+ years in industry
• Significant late-stage/registrational trial leadership
• Prior medical monitoring and NDA/BLA support

Responsibilities

• Oversee design and execution of Phase 2/3 and registrational studies; provide medical oversight and contribute to regulatory strategies.
• Support submissions to agencies like FDA and EMA; collaborate with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety.
• Engage with external KOLs and investigators; mentor team members.

Skills

Medical leadership

Late-stage leadership

Regulatory strategy

Cross-functional collaboration

Education

MD or equivalent

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

Job description

Executive Director, Clinical Development

Leading Mineralys' clinical programs targeting hypertension and related conditions, including CKD and OSA.

Responsibilities

• oversee trial design and execution for Phase 2/3 and registrational studies, provide medical oversight, contribute to regulatory strategies, and support submissions to agencies like FDA and EMA.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety teams; engage with external KOLs and investigators; and mentor team members.

Requirements

• MD or equivalent, board certification preferred in Internal Medicine, Cardiology, Nephrology, or Endocrinology; 10+ years of industry experience with significant late-stage/registrational trial leadership, including prior medical monitoring and NDA/BLA support.

High-Value

• focus on hypertension, cardiovascular, renal, or metabolic diseases; experience in global clinical development, safety surveillance, and regulatory interactions.

WorkSetup

Fully remote; leadership in a fast-paced biotech environment.