Executive Director, Clinical Development & Medical Affairs
Humacyte
June 25, 2026
Remote friendly (Durham, NC)
United States
Clinical Research and Development
Job Summary
The Executive Director, Clinical Development & Medical Affairs is responsible for leadership and oversight of the clinical development and corporate medical affairs strategy and execution. Seats on the CMO leadership team; reports into the Chief Medical Officer.
Essential Functions
- Provide strategy, direction and oversight for global clinical trials (with the Executive Director of Clinical Operations).
- Develop, Own and Execute the Clinical Development Plan.
- Lead execution of post-approval clinical studies for Trauma indications.
- Design clinical development plans for CABG studies and life-cycle indications such as PAD.
- Provide medical oversight; participate in review/development of study protocols, Investigator Brochure (IB), Clinical Study Reports (CSR), and clinical aspects of regulatory dossiers.
- Develop and guide corporate medical affairs strategy across indications.
- Collaborate with external thought leaders, Field Medical Affairs and Commercial for label expansion and life-cycle initiatives.
- Guide (as appropriate) Medical Legal Regulatory (MLR) review team for presentations, publications, press releases and sales material as clinical/medical subject matter expert.
- Represent company at selected conferences, advisory boards, and regulatory interactions.
- Collaborate with Regulatory & Quality to ensure proactive compliance.
- Provide personnel management for direct reports (recruitment, retention, performance management, career development).
Experience & 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 background in clinical trials and pharma drug/biologic development process.
- Medical Affairs experience.
- Ability to lead executive strategy and policy discussions.
- Excellent communication/interpersonal skills; collaborative, fast-paced environment experience.
Compensation & Benefits Highlights
- Stock options; 401k with 4% match; medical/vision/dental; paid disability and life insurance; 23 days PTO; 10 holidays + 2 floating; 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.
The Executive Director, Clinical Development & Medical Affairs is responsible for leadership and oversight of the clinical development and corporate medical affairs strategy and execution. Seats on the CMO leadership team; reports into the Chief Medical Officer.
Essential Functions
- Provide strategy, direction and oversight for global clinical trials (with the Executive Director of Clinical Operations).
- Develop, Own and Execute the Clinical Development Plan.
- Lead execution of post-approval clinical studies for Trauma indications.
- Design clinical development plans for CABG studies and life-cycle indications such as PAD.
- Provide medical oversight; participate in review/development of study protocols, Investigator Brochure (IB), Clinical Study Reports (CSR), and clinical aspects of regulatory dossiers.
- Develop and guide corporate medical affairs strategy across indications.
- Collaborate with external thought leaders, Field Medical Affairs and Commercial for label expansion and life-cycle initiatives.
- Guide (as appropriate) Medical Legal Regulatory (MLR) review team for presentations, publications, press releases and sales material as clinical/medical subject matter expert.
- Represent company at selected conferences, advisory boards, and regulatory interactions.
- Collaborate with Regulatory & Quality to ensure proactive compliance.
- Provide personnel management for direct reports (recruitment, retention, performance management, career development).
Experience & 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 background in clinical trials and pharma drug/biologic development process.
- Medical Affairs experience.
- Ability to lead executive strategy and policy discussions.
- Excellent communication/interpersonal skills; collaborative, fast-paced environment experience.
Compensation & Benefits Highlights
- Stock options; 401k with 4% match; medical/vision/dental; paid disability and life insurance; 23 days PTO; 10 holidays + 2 floating; 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.