Vice President - Clinical Development, Evidence, and Strategy
New
Remote - USFull-TimeVp
Salary266,000 - 346,000 USD per year
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Job Details
- Experience
- 12+ years of leadership experience
- Required Skills
- Artificial IntelligenceData management
Requirements
- M.D. or equivalent advanced degree in medicine.
- Additional research degree (M.S. or Ph.D.) highly desirable.
- 12+ years of leadership experience in clinical research or scientific functions within academic, health system, medical device, diagnostics, or pharma/biotech industries.
- Proven track record of leading pivotal FDA studies (IDE, PMA, or NDA/BLA submissions) from design through approval.
- Expertise in clinical trial design, sample size estimation, and statistical methodology for Class II diagnostic devices.
- Demonstrated experience translating clinical evidence into regulatory approvals, payer coverage, and commercial adoption.
- Strong background in clinical strategy, real-world evidence generation, health outcomes, or epidemiology.
- Experience as a Principal Investigator for formative, user experience, human factors, and design validation studies.
- Experience managing and scaling multi-disciplinary teams including science and data functions.
- Excellent communication and collaboration skills with ability to influence at executive and board levels.
Responsibilities
- Lead the company’s overarching clinical strategy, integrating regulatory, clinical, and commercial considerations.
- Architect the clinical narrative to support product differentiation, indications, labeling, and reimbursement.
- Define and validate clinical use cases based on unmet clinical needs and technical feasibility.
- Oversee the design and execution of pivotal FDA and global regulatory studies.
- Integrate real-world evidence and comparative effectiveness research into regulatory submissions and payer dossiers.
- Lead and scale multidisciplinary teams spanning clinical development, science, biostatistics, data management, and data engineering.
- Serve as a primary clinical voice for interactions with regulatory agencies, professional societies, and academic partners.
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