Humacyte

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 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 .

JOB SUMMARY:

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.

ESSENTIAL FUNCTIONS:

• 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.
  
  

EXPERIENCE & QUALIFICATIONS:

• MD required
• 7-10 years of relevant pharma experience, required. Vascular surgical experience preferred
• Recent NDA or BLA experience preferred
• 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.
  
  

COMPENSATION & BENEFITS HIGHLIGHTS:

• 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
  
  

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3 rd 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.