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 as a medical monitor and clinical lead for Phase 2/3 studies.
Proven experience supporting NDA/BLA submissions and interacting with health authorities.
Strong understanding of GCP, ICH guidelines, safety reporting, and global clinical development processes.
Proven 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 preferred.
Responsibilities
Serve as the clinical lead for clinical programs, overseeing trial design and execution.
Lead the development of clinical plans, protocols, and amendments.
Provide medical oversight for Phase 2/3 registrational studies, ensuring safety and data integrity.
Collaborate cross-functionally to ensure efficient study execution and issue resolution.
Drive key milestones including study start-up, enrollment, interim analyses, and data reporting.
Act as the medical monitor for assigned studies, reviewing safety signals and protocol deviations.
Contribute to global regulatory strategy and author clinical regulatory documents.
Benefits
Medical, dental, and vision insurance.
Paid time off and 401(k) plan.
Participation in incentive plans contingent on performance.
Standard company benefits.
Full Job Description
Executive Director, Clinical Development
The Executive Director, Clinical Development will serve as the clinical lead for development program(s) and play a critical role in advancing pivotal studies, regulatory strategy, and submission readiness. This physician leader will provide medical and scientific oversight across the program lifecycle, from protocol design and study execution through data interpretation, regulatory interactions, and launch preparation.
This role requires a hands-on clinical development leader who thrives in a fast-paced biotech environment and can partner cross-functionally to drive high-quality execution with urgency.
Key Responsibilities:
Clinical Development Leadership
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.
Medical Monitoring / Safety Oversight
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.
Regulatory / Submission Support
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.
Scientific / Cross-Functional 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.
Team / Culture Leadership
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.
Experience and Qualifications:
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.
These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
