VP, Clinical Development & Medical Affairs
Humacyte
August 31, 2026
Remote friendly (Durham, NC)
United States
Clinical Research and Development
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.
Application instructions:
- Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from third-party firms/agency recruiters.
- 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.
Application instructions:
- Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from third-party firms/agency recruiters.