MDWerks is a forward-thinking company that is leading the charge in the world of sustainable technology.
Executive Director, Clinical Development
Location
United States
Posted
39 days ago
Salary
$340K - $370K / year
Seniority
Lead
Job Description
Executive Director, Clinical Development
MDWerks Inc.
• 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.
Job 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.
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
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