Executive Director, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the clinical leader for one or more clinical programs, managing clinical trial design, execution, and critical milestones.

• Oversee the development of clinical plans, protocols, amendments, and associated study documents.

• Ensure patient safety, data integrity, and operational excellence by providing medical oversight for Phase 2/3 and/or registrational studies.

• Collaborate with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety teams.

• Lead study start-up activities, enrollment, interim analyses, database locks, topline results, and the delivery of Clinical Study Reports (CSRs).

• Function as the medical monitor by reviewing eligibility, protocol deviations, safety signals, serious adverse events (SAEs)/adverse events (AEs), and conducting benefit-risk assessments.

• Work with Pharmacovigilance on safety surveillance, signal detection, DSMB materials, and aggregate safety reporting.

• Assist in risk mitigation strategies and ensure patient safety throughout the execution of the program.

• Contribute to the global regulatory strategy and engage with health authorities such as the FDA, EMA, PMDA, and others.

• Draft and review clinical sections of regulatory documents, including briefing materials, protocols, CSRs, Investigator Brochures (IBs), and submission modules.

• Present clinical data and strategies to regulators, internal governance committees, and senior leadership.

• Serve as the primary clinical representative on cross-functional program teams.

• Collaborate with Translational Medicine, Biomarkers, Medical Affairs, and Commercial teams.

• Assist in publication planning, congress presentations, and external scientific engagements.

• Establish relationships with key opinion leaders (KOLs), investigators, and external experts.

• Mentor internal team members and external consultants/CRO partners.

• Promote collaboration, accountability, urgency, and quality within a lean biotech setting.

⛳️ Requirements

• An MD or equivalent medical degree is required.

• Board certification is preferred in Internal Medicine, Cardiology, Nephrology, Endocrinology, or a related field.

• A minimum of 10 years of experience in industry clinical development, with substantial leadership in late-stage/registrational trials.

• Previous experience as a medical monitor and clinical lead for Phase 2/3 studies is essential.

• Demonstrated experience with NDA/BLA submission support and interactions with health authorities.

• Strong knowledge of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, safety reporting, and global clinical development procedures.

• Proven capability to lead cross-functional teams and influence stakeholders without direct authority.

• Excellent scientific communication and presentation skills are required.

• Experience in hypertension, cardiovascular, renal, or metabolic diseases is highly preferred.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Paid time off

• 401K plan

• Participation in Mineralys incentive plans, contingent on achieving personal and company performance goals