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 .

Posted 4/21/2026full-timeRemote • 🇺🇸 United StatesLead💰 $340,000 - $370,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial designclinical plans developmentprotocol amendmentsmedical oversightrisk mitigation strategiesregulatory document authoringsafety surveillancesignal detectionNDA submission supportBLA submission support

Soft Skills

leadershipcollaborationmentoringcommunicationpresentation skillsinfluence without authorityrelationship buildingaccountabilityurgencyquality focus

Certifications

MDboard certification in Internal Medicineboard certification in Cardiologyboard certification in Nephrologyboard certification in Endocrinology