VP, Clinical Development & Medical Affairs

Responsibilities:

• Provide strategy, direction, and oversight for global clinical trials in close partnership with the Executive Director of Clinical Operations.
• Develop, own, and execute the Clinical Development Plan.
• Lead execution of post-approval clinical studies for the Trauma indication.
• Design clinical development plans for CABG studies and other life-cycle indications such as PAD (Peripheral Arterial Disease).
• Provide medical oversight and participate in review/development of Study Protocols, Investigator Brochure (IB), Clinical Study Reports (CSR), and clinical sections of regulatory dossiers.
• Develop and guide execution of corporate medical affairs strategy across indications.
• Collaborate with external thought leaders, Field Medical Affairs, and Commercial (label expansion and life-cycle management).
• Direct MLR review for company presentations, publications, press releases, and sales materials as clinical/medical subject matter expert.
• Represent the company at selected conferences, advisory boards, regulatory interactions, and other meetings.
• Collaborate with Regulatory & Quality to ensure proactive compliance.
• Provide personnel management for team direct reports (recruitment, retention, performance management, career development).

Qualifications:

• MD required.
• 7–10 years relevant pharma experience (vascular surgical experience preferred).
• Recent NDA or BLA experience preferred.
• 5–7 years progressively responsible people leadership experience.
• Knowledge of ICH/GCP/FDA and country-specific regulations for medical devices and/or pharma/biologics.
• Strong clinical trials and drug/biologic development background.
• Medical Affairs experience.

Skills:

• Lead discussions with executive management on strategy and policy.
• Excellent communication and interpersonal skills.
• Positive, roll-up-the-sleeves, optimistic, critical thinker.
• Ability to work in fast-paced, cross-functional environments; strong organization and time management.

Benefits:

• Stock options; 401k with 4% match; medical, vision, and dental; company-paid disability and life insurance; 23 days PTO; 10 company holidays + 2 floating holidays; paid parental leave.