Executive Director, Clinical Development & Medical Affairs

HUMACYTE GLOBAL INC•Durham, NC

4d•Hybrid

About The Position

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 grafts, 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 [http://www.humacyte.com/]. The Executive Director, Clinical Development & Medical Affairs is responsible for leadership and oversight of the clinical development and corporate medical affairs strategy and execution. 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.

Requirements

MD required
7-10 years of relevant pharma experience, required.
5-7 years of progressively responsible people leadership experience
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
Medical Affairs Experience
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 and demonstrated ability to collaborate within cross functional teams.
Excellent organizational and time management skills with ability to set own priorities in a timely manner.
Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
Represents the organization in a positive and highly professional manner.

Nice To Haves

Vascular surgical experience preferred
Recent NDA or BLA experience preferred

Responsibilities

Provide strategy, direction and oversight for the management of global clinical trials working closely with the Executive Director of Clinical Operations
Develop, Own and Execute the Clinical Development Plan
Lead the execution of post approval clinical studies for Trauma Indication
Design Clinical Development Plan for CABG studies and other life cycle indications such as PAD (Peripheral arterial Disease)
Provide Medical Oversight, participate in review and development of Study Protocols, Investigator Brochure (IB), Clinical Study Reports (CSR), and Clinical aspects of Regulatory dossiers
Develop and guide the execution of the corporate medical affairs strategy across different indications
Collaborate with External Thought Leaders, Humacyte Field Medical Affairs and Commercial as needed particularly for label expansion and life cycle management studies/initiatives
Provide guidance and as appropriate direct the Medical Legal Regulatory (MLR) review team for company presentations, publications, press releases and sales material as the clinical and medical subject matter expert
Represent Humacyte at selected Conferences, Advisory Boards, Regulatory interactions and other meetings
Collaborate with Regulatory & Quality to ensure proactive compliance with appropriate regulations
Provide all personnel management for team direct reports (as applicable) to include, recruitment, retention, performance management, and career development
Other Duties as assigned.