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 :
Medical Monitor:
EXPERIENCE & QUALIFICATIONS:
Required experience and skills for Executive Director, Clinical Development & Medical Monitoring:
Minimum education required for Senior Medical Writer:
COMPENSATION & BENEFITS HIGHLIGHTS:
** 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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