Executive Director, Head of Clinical Monitoring and Safety

Unclassified - Durham, NC

Full-time - Executive

Hybrid - Durham, NC

About the position

Humacyte Inc (Nasdaq: HUMA) is at the forefront of developing a groundbreaking biotechnology platform aimed at delivering universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems. The Executive Director, Head of Clinical Monitoring and Safety, plays a pivotal role in leading and overseeing the clinical and medical monitoring of all clinical trials, as well as ensuring safety and pharmacovigilance post-launch. This position requires a deep understanding of clinical trial data and the ability to interpret it effectively, as well as experience in medical monitoring and collaboration with Contract Research Organizations (CROs). The Executive Director will be a key member of the leadership team, interfacing with various functions such as regulatory, commercial, medical affairs, quality, manufacturing, and finance to drive strategic initiatives. In this role, the Executive Director will provide strategic direction and medical oversight for clinical trials, participate in the review and development of essential documents such as protocols, Investigator Brochures, Clinical Study Reports, and Safety Update Reports. They will lead the design and conduct of post-marketing pharmacovigilance studies, working closely with the clinical operations team and CROs to ensure high-quality data delivery from clinical trials. The Executive Director will also be responsible for developing and managing Key Performance Indicators (KPIs) to track the progress of ongoing clinical studies and ensure compliance with regulatory requirements. The position requires excellent communication and interpersonal skills, as the Executive Director will represent Humacyte at conferences and meetings, influence key stakeholders, and manage a team of safety professionals. The ideal candidate will possess a positive attitude, strong organizational skills, and the ability to thrive in a fast-paced environment with fluctuating priorities. This role is critical to ensuring that clinical studies are conducted in accordance with established guidelines and regulations, ultimately contributing to the advancement of Humacyte's innovative therapies.

Responsibilities

• Provide strategy, direction, and medical oversight for clinical trials.
• Contribute as a key member of the leadership team and interface with other functions such as regulatory, commercial, medical affairs, quality, manufacturing, and finance.
• Participate in the review and development of protocols, Investigator Brochures, Clinical Study Reports, and Safety Update Reports.
• Lead the design and conduct of post-marketing pharmacovigilance studies.
• Work with clinical operations team and CROs to provide medical monitoring expertise and data interpretation.
• Develop, monitor, and manage Key Performance Indicators (KPIs) for ongoing clinical studies.
• Manage day-to-day activities associated with the conduct of clinical studies.
• Review and approve study plans and safety documents to ensure compliance.
• Ensure appropriate training of team members and CRO staff.
• Represent Humacyte at selected conferences and meetings.
• Collaborate with Regulatory & Quality to ensure compliance with regulations on clinical trial conduct and safety reporting requirements.
• Provide personnel management for safety team direct reports, including recruitment and performance management.

Requirements

• M.D. degree is required.
• 10+ years of relevant industry experience is required; vascular experience is highly preferred.
• Both sponsor (CRO oversight) and CRO experience is desirable.
• Recent NDA or BLA experience is preferred.
• Excellent knowledge of ICH/GCP/FDA and other country-specific regulations and guidelines for pharmaceutical/biologic agents.
• Strong background in medical monitoring and conducting and managing clinical trials.
• Ability to lead discussions with executive management team on strategy and policy issues.
• Excellent communication and interpersonal skills.
• Strong ability to work in a fast-paced team environment with fluctuating priorities.
• Excellent organizational and time management skills.

Nice-to-haves

• Experience with compassionate use (expanded access) requests.
• Experience in advising on pre-clinical studies for new product development.

Benefits

• Stock options
• Paid parental leave
• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• Paid time off
• 401(k) with 4% match
• Vision insurance
• Life insurance