Executive Director, Clinical Development & Medical Affairs

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. Reports to the Chief Medical Officer and sits on the CMO leadership team.

Essential Functions / Responsibilities:
- 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 post-approval clinical studies for Trauma indication.
- Design clinical development plans for CABG studies and other life cycle indications such as PAD.
- Provide medical oversight for study protocols, Investigator Brochure (IB), Clinical Study Reports (CSR), and clinical portions 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 management.
- Guide/direct the Medical Legal Regulatory (MLR) review team for presentations, publications, press releases, and sales material 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 direct reports (recruitment, retention, performance management, career development).

Experience & Qualifications (Required/Preferred):
- MD required.
- 7–10 years relevant pharma experience (vascular surgical experience preferred).
- Recent NDA or BLA experience preferred.
- 5–7 years progressive people leadership.
- Knowledge of ICH/GCP/FDA and country-specific regulations for medical devices and/or pharma/biologics.
- Strong background in conducting clinical trials and drug/biologic development.
- Medical Affairs experience.

Skills:
- Ability to lead executive-level strategy/policy discussions.
- Excellent communication and interpersonal skills; positive, roll-up-the-sleeves attitude.
- Strong cross-functional collaboration in fast-paced environments; strong organizational/time management.
- Self-motivated critical thinker with strong business communication.

Compensation & Benefits Highlights:
- Stock options; 401k with 4% match; medical/vision/dental; company-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.