Senior Director, Medical Affairs – Vascular Platform

Role Overview

• Provide strategic medical and clinical leadership for innovation and new product development, including concept ideation, cross‑functional collaboration, and definition of clinical evidence requirements for regulatory approval, safety, and efficacy.
• Define and guide global pre‑market and post‑market clinical evidence strategies to support registration, reimbursement, and market adoption.
• Lead strategic KOL engagement, including oversight of advisory boards, ensuring high‑quality scientific exchange, actionable insights for cross‑functional teams, and full compliance with regulatory and ethical standards.
• Support long‑term business growth through medical due diligence for mergers, acquisitions, partnerships, and integrations; identify and communicate medical risks and implications to senior leadership.
• In partnership with Medical Safety leadership, oversee medical safety and risk management for the Vascular portfolio, ensuring compliance with global regulatory requirements (e.g., FDA, PMDA, Notified Bodies, GLPs) and providing clinical expertise for adverse event assessment, post‑market surveillance, risk management planning, safety communications, and Field Action Committee activities.
• Contribute to the Innovation Council by identifying emerging technologies, assessing unmet clinical needs, and evaluating new product concepts.
• Review and provide medical input on Investigator‑Initiated Study (IIS) proposals for business consideration; oversee or coordinate preclinical studies as required.
• Lead and develop a high‑performing Medical Affairs team, ensuring appropriate training, coaching, and performance management across roles, including global Medical Affairs teams and Medical Science Liaisons.
• Engage early and continuously with cross‑functional partners, including Marketing, Regulatory, R&D, Clinical Affairs, Quality, Business Development, Scientific Affairs, Physician Training, and Global Medical Affairs Regions to align medical strategy with program and platform objectives.
• Partner with Marketing to assess the scientific and clinical validity of product claims and ensure medical accuracy and promotional compliance.
• Collaborate with Clinical Affairs on clinical trial design, execution, analysis, and interpretation, including endpoint selection and patient population strategy.
• Shape publication and presentation strategies in partnership with Scientific Affairs to maximize scientific credibility and business impact.
• Support regulatory submissions, labeling development, medical information responses, and ad hoc medical expertise requests, including Legal support, ensuring scientific rigor and compliance.

Requirements

• Medical Doctor (MD or DO) degree from an accredited institution required.
• Clinical training or practice experience in Vascular Surgery, Endovascular Medicine, Interventional Cardiology, or Interventional Radiology strongly preferred.
• Minimum 8+ years of progressive scientific and medical leadership experience, with demonstrated authority and credibility in medical decision‑making.
• Experience in the medical device industry preferred, particularly supporting device‑based vascular therapies and peripheral vascular interventions.
• Prior experience in a Medical Affairs leadership role or equivalent, with a proven ability to engage, influence, and align senior internal and external stakeholders.
• Demonstrated expertise in clinical evidence generation across the product lifecycle, including pre‑market and post‑market activities.
• Experience with medical device safety, risk management, and post‑market surveillance, with the ability to apply clinical data to inform strategy and business decisions.
• Strong knowledge of global medical device regulatory pathways and clinical evidence requirements, including FDA (510(k), PMA), CE Mark, and post‑market obligations.
• Inclusive, values‑based leadership style with the ability to influence, negotiate, and shape organizational culture.
• Proven people leadership capabilities, including the ability to develop talent, lead through change, and drive aligned execution across teams.
• Excellent communication skills, with the ability to distill complex scientific and clinical information into clear, actionable insights.
• Strong relationship‑building skills, fostering trust and collaboration with cross‑functional partners and external stakeholders.
• High adaptability to evolving platform needs, diverse perspectives, and dynamic business environments.
• Deep understanding of ethical, compliance, and governance standards within Medical Affairs.

Benefits

• Health insurance
• 401(k) matching
• Flexible working hours
• Paid time off
• Professional development opportunities