Job Description

Job Description

Job Description

DEPARTMENT: Clinical Operations

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

JOB SUMMARY:

The Executive Director, Clinical Development & Medical Monitoring, is responsible for the leadership and oversight of clinical development, global clinical trials management and Clinical Research Organization (CRO) partnerships. This position requires strong influencing and negotiation skills and the ability to

introduce innovative and strategic concepts to both internal and external partners and stakeholders. This role seats on the CMO leadership team and reports into the Chief Medical Officer.

Essential Functions in the role of Executive Director, Clinical Development & Medical Monitoring:

Clinical Development Strategy :

• Provide strategy, direction and oversight for the management of global clinical trials to include vendor selection, vendor management, day to day operational oversight of CRO partners and other clinical trial vendors
• Develop, Own and Execute the Clinical Development Plan
• Lead the design and conduct of post approval clinical studies for Trauma Indication
• Woking closely with Head of Clinical Operations assume responsibility for the Clinical Development Budget including review and approval of contracts, work orders and invoices within grant of authority
• Provide Medical Oversight, participate in review and development of protocols, Investigator Brochure (IB), Clinical Study Reports (CSR), Development Safety Update Report (DSUR), Development Plans to ensure alignment with strategic plans of the organization
• 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
• Work with Head of Clinical Operations to manage day-to-day activities associated with the conduct of clinical studies.
• Identify need for, develop and/or review clinical SOPs as needed
• Represent Humacyte at selected conferences, Advisory Boards, Regulatory interactions and other meetings
• Collaborate with Regulatory & Quality to ensure proactive compliance with appropriate regulations
• Collaborate with Medical Affairs and Commercial as needed particularly for label expansion and life cycle management studies/initiatives
• Effectively influence key internal and external stakeholders regarding matters of significance related to clinical trial management and clinical deliverables utilizing data and knowledge of company strategy as related to clinical trial management
• Provide all personnel management for clinical team direct reports to include, recruitment, retention, performance management, and career development

Medical Monitor:

• Ensuring that Humacyte Clinical Studies run by
  1. Providing medical oversight and valuating patient data
     1. Coordinating with members of Humacyte’s clinical operations team to ensure that clinical trial sites are complying with procedures and have the necessary information and equipment to operate the study successfully
     2. Collaborating with Medical Affairs and surgical consultants to ensure study site visits happen as planned
     3. Collaborating with Data Management lead in ensuring high quality data capture from our clinical sites
• Responsible for monitoring ongoing patient follow-up for our AV access and Trauma studies
• Assist New Product Development (NPD) team on future indications such as CABG, including advising on pre- clinical studies

EXPERIENCE & QUALIFICATIONS:

Required experience and skills for Executive Director, Clinical Development & Medical Monitoring:

• Excellent knowledge of ICH/GCP/FDA and other country specific regulations and guidelines for medical devices and/or pharmaceutical/biologic agents
• Strong background in conducting clinical trials and pharmaceutical industry drug/biologic development process
• Ability to lead discussions with executive management team on strategy and policy issues

Minimum education required for Senior Medical Writer:

• MD required
• 7-10 years of relevant pharma experience, required. Vascular experience, preferred
• Both sponsor (CRO oversight) and CRO experience highly desirable
• Recent NDA or BLA experience preferred5-7 years of progressively responsible people leadership experience

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

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

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.

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