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, responsible for the design of clinical trials, oversight of execution, and achievement of key milestones.

• Spearhead the creation of clinical plans, protocols, amendments, and associated study documentation.

• Provide medical oversight for Phase 2/3 and/or registrational studies, ensuring the safety of patients, integrity of data, and operational excellence.

• Collaborate with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Safety to guarantee efficient study execution and prompt issue resolution.

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

• Function as the medical monitor for assigned studies, which includes reviewing eligibility, protocol deviations, safety signals, serious adverse events (SAEs) and adverse events (AEs), and benefit-risk assessments.

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

• Assist in developing risk mitigation strategies while prioritizing patient safety throughout the execution of programs.

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

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

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

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

• Collaborate with Translational Medicine, Biomarkers, Medical Affairs, and Commercial teams to align the development strategy with future launch requirements.

• Assist in publication planning, conference presentations, and external scientific engagement.

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

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

• Cultivate a culture of collaboration, accountability, urgency, and quality.

• Function effectively in a lean biotech environment where flexibility and ownership are essential.

⛳️ Requirements

• An MD or equivalent medical degree is required; board certification in Internal Medicine, Cardiology, Nephrology, Endocrinology, or a related field is preferred.

• Over 10 years of clinical development experience in the industry, including substantial leadership in late-stage and registrational trials.

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

• Proven experience in supporting NDA/BLA submissions and engaging with health authorities.

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

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

• Excellent scientific communication and presentation abilities.

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

🏝️ Benefits

• These positions qualify for standard company benefits, which include medical, dental, vision, time off, and a 401K plan.

• Participation in Mineralys incentive programs is contingent on achieving personal and company performance goals.