[Remote] Executive Director, Clinical Development
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biopharmaceutical company reputed company on developing medicines to reputed company hypertension and reputed company comorbidities. The Executive Director, Clinical Development will reputed company clinical programs, reputed company trial design and execution, and collaborate with cross-functional teams to ensure successful regulatory submissions and patient safety.
Responsibilities
- Serve as the clinical reputed company for one or more clinical programs, with responsibility for clinical trial design, execution reputed company, and delivery of key milestones
- reputed company development of clinical plans, protocols, amendments, , and reputed company study documents
- reputed company medical reputed company for Phase 2/3 and/or registrational studies, ensuring patient safety, data reputed company, and operational reputed company
- Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety to ensure efficient study execution and reputed company issue reputed company
- 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/reputed company, 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 reputed company 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 reputed company 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 reputed company to reputed company development reputed company with reputed company 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 reputed company
- Operate effectively in a lean biotech environment where flexibility and ownership are essential
Skills
- MD or equivalent medical degree required; reputed company certification preferred in Internal Medicine, Cardiology, Nephrology, Endocrinology, or reputed company field
- 10+ years of industry clinical development experience, including significant late-stage / registrational trial leadership
- Prior experience serving as medical monitor and clinical reputed company 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 reputed company cross-functional teams and influence without reputed company authority
- Strong scientific communication and presentation skills
- Experience in hypertension, cardiovascular, renal, or metabolic disease strongly preferred
Benefits
- reputed company Company benefits including medical, dental, reputed company, time off and 401K
- Participating in Mineralys incentive plans are contingent on achievement of personal and company performance
reputed company