Executive Director, Clinical Development

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

📋 Description

• Act as the clinical lead for one or more clinical programs, managing the design, execution, and key milestones of clinical trials.

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

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

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

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

• Function as the medical monitor, reviewing eligibility criteria, protocol deviations, safety signals, Serious Adverse Events (SAEs) and Adverse Events (AEs), and benefit-risk assessments.

• Work together with Pharmacovigilance on safety surveillance, signal detection, Data Safety Monitoring Board (DSMB) materials, and aggregate safety reporting.

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

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

• Write and review clinical sections of regulatory documents, which include briefing books, protocols, CSRs, Investigator's Brochures (IBs), and submission modules.

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

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

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

• Aid in publication planning, congress presentations, and external scientific engagement efforts.

• Establish relationships with Key Opinion Leaders (KOLs), investigators, and external experts.

• Mentor internal team members as well as external consultants and Clinical Research Organization (CRO) partners.

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

⛳️ Requirements

• An MD or equivalent medical degree is required.

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

• A minimum of 10 years of industry experience in 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 necessary.

• Demonstrated experience supporting NDA/BLA submissions and interacting with health authorities.

• In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, safety reporting, and global clinical development processes.

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

• Exceptional scientific communication and presentation abilities are essential.

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

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Time off

• 401K

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