Executive Director, Clinical Development

Role Overview

• Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones
• Lead development of clinical plans, protocols, amendments, , and related study documents
• Provide medical oversight for Phase 2/3 and/or registrational studies, ensuring patient safety, data integrity, and operational excellence
• Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety to ensure efficient study execution and timely issue resolution
• Drive study start-up, enrollment, interim analyses, database locks, topline results, and CSR delivery
• Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments
• Collaborate with Pharmacovigilance on safety surveillance, signal detection, DSMB materials, and aggregate safety reporting
• Support development of risk mitigation strategies and ensure patient safety remains central throughout program execution
• Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.)
• Author and review clinical sections of regulatory documents, including briefing books, protocols, CSRs, IBs, and submission modules
• Present clinical data and strategy to regulators, internal governance committees, and senior leadership
• Serve as the key clinical voice on cross-functional program teams
• Partner with Translational Medicine, Biomarkers, Medical Affairs and Commercial to align development strategy with future launch needs
• Support publication planning, congress presentations, and external scientific engagement
• Build strong relationships with KOLs, investigators, and external experts
• Mentor internal team members and external consultants/CRO partners
• Foster a culture of collaboration, accountability, urgency, and quality
• Operate effectively in a lean biotech environment where flexibility and ownership are essential.

Requirements

• 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
• Prior experience serving as medical monitor and clinical lead for Phase 2/3 studies
• Proven experience with 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
• Strong scientific communication and presentation skills
• Experience in hypertension, cardiovascular, renal, or metabolic disease strongly preferred.

Tech Stack

• Google Cloud Platform

Benefits

• These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K
• Participating in Mineralys incentive plans are contingent on achievement of personal and company performance