Job Description

We are seeking an experienced VP of Clinical Science to lead clinical science and scientific affairs for our Class III program. This is a high-impact leadership role responsible for designing and executing the clinical evidence strategy required for a successful PMA, while building a strong scientific foundation through KOL engagement, publications, and medical education. The ideal candidate is both a rigorous clinical scientist and a strategic leader who can operate hands-on in a startup environment while preparing the organization for clinical trials and regulatory success.

Role Responsibilities

• Own the clinical evidence strategy in support of the Class III PMA pathway, including IDE strategy, pivotal trial design, endpoints, and statistical considerations.
• Lead the development of clinical protocols, investigator brochures, clinical investigation plans, and related study documents.
• Drive clinical data interpretation, evidence synthesis, and preparation of clinical sections for regulatory submissions.
• Partner closely with Regulatory, Quality, and R&D to ensure clinical evidence aligns with design controls, risk management, and overall product strategy.
• Lead scientific affairs strategy, including KOL identification, advisory board development, and long-term scientific partnerships.
• Drive publication and congress strategy (abstracts, manuscripts, presentations) to build clinical awareness and scientific credibility.
• Represent the company at key scientific and medical meetings; support medical education and training initiatives.
• Serve as a scientific spokesperson with clinicians, investigators, and external stakeholders.
• Provide clinical and scientific input to Board updates, investor materials, and due diligence processes.
• Contribute to reimbursement and health economics strategy through clinical evidence planning.

Qualifications

Required Qualifications

• Advanced degree (MD, PhD, PharmD, or equivalent) in a relevant scientific or clinical field;
• Demonstrated success leading clinical strategy and evidence generation for at least one Class III PMA (or equivalent high-risk pathway).
• Strong expertise in clinical trial design, endpoints, biostatistics interpretation, and GCP/FDA clinical regulations.
• Proven ability to engage and manage KOLs, build advisory boards, and drive high-impact publications and scientific communications.
• Experience operating in a startup or high-growth environment, with comfort being both strategic and hands-on.
• Excellent written and verbal communication skills; ability to translate complex clinical science for diverse audiences (regulators, investors, clinicians, Board).

Preferred Qualifications

• Direct experience with IDE submissions, pivotal trial execution, and PMA clinical modules.
• Background in complex devices (e.g., implants, interventional systems, or software-enabled technologies).
• Prior leadership of a clinical or scientific affairs function in a Series A–C company.
• Experience contributing to health economics/outcomes research or reimbursement strategy.
• Existing network of relevant KOLs and investigators in the target therapeutic area.