Vice-President Clinical Affairs (MedTech)

Location: Preferred locations include Raritan, New Jersey, or Cincinnati, Ohio, United States. Remote work in the US may be considered case by case with company approval.

Annual base pay range: $218,000–$401,350, plus eligibility for an annual performance bonus and long-term incentive program.

Company

Healthcare innovation organization developing smarter, less invasive, and personalized medical technologies and surgical solutions.

What you will do

• Define clinical and evidence-generation strategies across the product portfolio, from pre-clinical development through post-market activities.
• Lead a multidisciplinary organization covering clinical research, clinical operations, clinical evaluation, medical writing, biostatistics, data science, and pre-clinical functions.
• Oversee first-in-human, pivotal, registry, observational, real-world evidence, and post-market studies.
• Provide leadership for statistical planning, data analysis, data management, and modern analytics, including AI/ML where applicable.
• Support regulatory submissions, technical documentation, labeling, inspections, and relationships with regulators, investigators, CROs, academic partners, and HTA bodies.
• Manage budgets, resources, vendors, timelines, quality systems, talent development, and progress reporting to executive leadership and the Board.

Requirements

• Advanced degree such as MS, MD, PhD, PharmD, or equivalent.
• 12+ years of progressive experience in clinical development, clinical operations, biostatistics/data science, or a related field, including at least 6 years in senior leadership.
• Experience leading multidisciplinary teams and complex global clinical programs, including pivotal trials and post-market studies.
• Strong knowledge of clinical trial design, biostatistics, clinical evaluation reports, pre-clinical-to-clinical translation, and real-world evidence.
• Experience with regulatory authorities, regulatory filings and inspections, and vendor/CRO oversight.
• Ability to travel globally approximately 20–40% depending on pipeline activities and external meetings.

Nice to have

• Experience with medical devices, combination products, biologics, or relevant therapeutic areas.
• MBA or another business degree.
• Knowledge of health economics, HTA requirements, payer evidence, and value dossiers.
• Experience with adaptive designs, decentralized trials, digital endpoints, registries, synthetic controls, and RWE methodologies.
• Experience with PMA, CE, IDE, 510(k), and post-approval submissions.

Culture & Benefits

• Patient-centered and ethical approach to clinical research with a focus on scientific rigor and data integrity.
• Inclusive work environment supporting individual differences and equal employment opportunity.
• Vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.
• Participation in pension and 401(k) savings plans.
• Eligibility for performance-based bonuses and a long-term incentive program.