Note: The job is a remote job and is open to candidates in USA. Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The Executive Director, Clinical Development will lead clinical programs, oversee trial design and execution, and collaborate with cross-functional teams to ensure successful regulatory submissions and patient safety.
Responsibilities
- 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
Skills
- 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
Benefits
- 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
Company Overview