Executive Director, Pharmacovigilance and Medical Monitoring

JOB TITLE: Executive Director, Pharmacovigilance and Medical Monitoring

DEPARTMENT:PV, Clinical

LOCATION: Durham, NC, Partially Remote

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass graft; pediatric heart surgery; treatment of type 1 diabetes; and multiple novel cell and tissue applications. Humacyte's 6mm ATEV for AV access in hemodialysis was the first product

candidate to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte's 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com.

JOB SUMMARY:

The Executive Director, Pharmacovigilance and Medical Monitoring is responsible for the leadership and oversight of Pharmacovigilance, Safety and Medical Monitoring at Humacyte. This individual must possess a strong knowledge of US and global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve PV challenges and facilitate PV Compliance. This role seats on the CMO leadership team and reports into the Chief Medical Officer.

Essential Functions in the role of Senior Director, Head of Pharmacovigilance:

Biological Product Safety

• Provide medical oversight of the PV function including medical review of all cases inclusive of case narratives and causality assessments of AE/SAE reports.
• Create and maintain a signal detection process (including regular and ad hoc reviews of aggregate safety data) for Humacyte products
• Coordinate safety governance within the company and ensure cross-functional involvement in the evaluation of potential emerging safety issues and any associated risk mitigation and management measures that are proposed.
• Participate as a key stakeholder in safety analyses and ensure proactive and timely benefit-risk assessments of safety data.
• Represent PV in communication with health and regulatory authorities including management of the DSUR process and being signatory for DSUR, PAER and other safety reports to FDA and other health authorities
• Represent Humacyte at independent Data Safety Monitoring Committee meetings.
• Design and implementation of Risk Management plans
• Compile analysis of adverse events of special interest (AESI), individual case comments, risk management plan implementation, and ad hoc safety analysis as required by health authorities or corporate policy.
• Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc).

Oversight of Safety operations:

• Experience in working with CROs handling clinical conduct and safety processes for ongoing studies
• Manage and direct Drug Safety operations staff to oversee case management functions ensuring process optimization, case quality, and accurate regulatory reporting.
• Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis.
• Determine processes and/or tools supporting PV signal management in accordance with GVP.

Safety Quality Metrics

• Ensure that company is always GVP inspection ready from FDA and other Global Health Authorities
• Ensure compliance of the PV system for all safety data sources in collaboration with cross functional stakeholders.
• Establish complementary GVP/GxP procedures for monitoring compliance with drug safety-related policies, procedures, applicable regulations, and agreements with contractual partners.
• Work with Quality to plan, conduct, and document internal and external GVP/GxP audits to assess compliance with applicable regulations, regulatory commitments, company SOPs, protocols, systems and contractual obligations as applicable.
• Manage the operational compliance of key and strategic vendors for partnership, participate in and support audits of contractual partners as necessary.
• Proactively identify procedural gaps and challenges and propose and implement solutions, lead the establishment of business process optimization efforts to ensure efficiency and process improvements with the department.
• Oversee PV department process and project management efforts.

Responsibilities as Head of PV

• Lead and supervise a high functioning PV team (2 to 5 direct reports)
• Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met.
• Work cross functionally aligning the company priorities with Clinical, Medical Affairs, pre-clinical and early development, Biometrics, Health economics & outcomes and Value access teams
• Perform all duties in keeping with Humactye's core values, policies and all applicable regulations.
• Responsible for Medical Monitoring activities

EXPERIENCE & QUALIFICATIONS:

• Medical Doctor (MD or x-US equivalent) with 15+ years of industry experience is required. Extensive industry experience and another relevant clinical degree (ie RN, MSN, NP) may be considered.
• 15 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred.
• Extensive experience interfacing with US Health Authorities in Safety/Pharmacovigilance areas required.
• Experience with BLA/sBLA submissions
• PV experience for products in clinical development and for post marketed products is a must
• Excellent scientific, clinical and analytical knowledge base, with ability to assess data and understand the safety and medical implications.
• In-depth understanding and experience with causality assessment science for adverse events
• Expert knowledge of the regulations governing pharmacovigilance.
• In-depth knowledge of Safety Science and Safety Operations disciplines, with a working knowledge of internally and externally managed safety systems and databases.
• Direct management experience with proven ability to effectively lead, coach, mentor, and manage others.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
• Strong learning orientation, curiosity, and commitment to science and patients

COMPENSATION & BENEFITS HIGHLIGHTS:

• Competitive base compensation and bonus
• 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
• Assortment of other voluntary benefits, including pet insurance; hospital indemnity; accident & critical illness plans; voluntary life insurance; legal protection plans and more
• 23 Days Paid Time Off (PTO) to start
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.