Executive Director, Head of Clinical Monitoring and Safety

Humacyte - Durham, NC

Full-time - Senior

Hybrid - Durham, NC

Chemical Manufacturing

About the position

The Executive Director, Head of Clinical Monitoring and Safety at Humacyte Inc is a pivotal leadership role responsible for 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 this data effectively. The Executive Director will provide strategic direction and medical oversight for clinical trials, contributing as a key member of the leadership team and collaborating with various functions such as regulatory, commercial, medical affairs, quality, manufacturing, and finance on strategic initiatives. In this role, the Executive Director will participate in the review and development of critical documents including protocols, Investigator Brochures (IB), Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Periodic Safety Update Reports (PSURs). They will lead the design and conduct of Post-Marketing Pharmacovigilance Studies and work closely with the clinical operations team and Contract Research Organizations (CROs) to provide medical monitoring expertise, ensuring the delivery of high-quality data from clinical trials. The Executive Director will also be responsible for developing, monitoring, and managing Key Performance Indicators (KPIs) to track the progress of ongoing clinical studies, ensuring compliance with SOPs, GCPs, ICH guidelines, and all applicable regulations. This role includes personnel management for the safety team, encompassing recruitment, retention, performance management, and career development. The Executive Director will represent Humacyte at selected conferences and meetings, collaborating with Regulatory & Quality teams to ensure compliance with clinical trial conduct and safety reporting requirements. Additionally, they will assist the New Product Development team on future indications, advising on pre-clinical studies as necessary.

Responsibilities

• Provide strategy, direction and medical oversight for the 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 in strategic initiatives.
• Participate in review & development of protocols, Investigator Brochures (IB), Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Periodic Safety Update Reports (PSURs).
• Lead the design and conduct of Post-Marketing Pharmacovigilance Studies.
• Work with clinical operations team and CROs to provide medical monitoring expertise, data interpretation, CRO query issuance and resolution, to ensure delivery of high-quality data from clinical trials.
• Contribute to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of ATEV and to meet regulatory requirements.
• Develop, monitor and effectively manage Key Performance Indicators (KPIs) to track the progress of the ongoing clinical studies as it relates to CRO and other vendor performance.
• Manage day-to-day activities associated with the conduct of clinical studies, including strategy for operationalization and site selection.
• Review and approve study plans and other safety documents to ensure CRO and vendor compliance.
• Ensure appropriate training of team members (including CRO staff).
• Ensure that clinical studies are conducted in accordance with SOPs, GCPs, ICH guidelines, and all applicable regulations as applies to safety of trial participants.
• Be a key interface and resource for investigators and vendors.
• Represent Humacyte at selected conferences and other meetings.
• Collaborate with Regulatory & Quality to ensure proactive compliance with appropriate regulations on clinical trial conduct and safety reporting requirements.
• Influence key internal and external stakeholders regarding clinical trial management and deliverables.
• Provide all personnel management for safety team direct reports including recruitment, retention, performance management, and career development.
• Collaborate with Medical Affairs in evaluating compassionate use requests and serve as the key medical expert for expanded access requests.
• Assist New Product Development team on future indications such as CABG.

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.
• Must be an accomplished organizational leader of people.
• 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.
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
• Strong ability to work in a fast-paced team environment with fluctuating priorities.
• Excellent organizational and time management skills with ability to set own priorities in a timely manner.
• High degree of flexibility and adaptability.
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills.

Nice-to-haves

• Experience in vascular clinical trials.
• Familiarity with compassionate use protocols.
• Experience with regulatory submissions and compliance.

Benefits

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies