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Chief Medical Officer

Leadership Team / Clinical | Research Triangle Park, NC | Full Time

Job Description

About Us:

Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies.  We are currently developing multiple vascular tissue engineered therapies and expanding our business model.  With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.

Responsibilities:

  •  Generate an overall strategy for the clinical development of Humacyte products that integrates the input of key opinion leaders (KOLs), delineation of unmet medical needs and the product development efforts within the organization

  • Serve on the executive leadership team for Humacyte

  • Serve as company safety officer
  • Medical oversight of all clinical trials to ensure patient safety regulatory requirements are being followed
  • Medical monitoring oversight
  • Develop study documents and reports, including IB, protocols and relevant sections of regulatory submissions (IND, BLA, renewals, etc)
  • Author relevant sections and conclusions of product safety profile for periodic safety aggregate reports such as DSUR, PSUR and IB
  • Development and execution of RMP or REMS risk mitigation activities
  • Work closely with Executive/Senior Leadership (Humacyte Leadership Team, HLT) and the CEO, set organizational goals and broad strategies for clinical development
  • Manage and lead the effective integration of Humacyte resources to accomplish goals and objectives
  • Help contribute to the intellectual property portfolio
  • Develop collaborations with surgeons and key opinion leaders in fields that are relevant to new product development; build new advisory boards as needed
  • Responsible for overall clinical development strategy
  • Full accountability for budget and clinical operations execution

Requirements:

  • Education:  MD or MD/PhD is required
  • Experience: At least 10 years post residency/internship experience ideally both in clinical practice/direct patient care as well as clinical development industry experience (within the pharmaceuticals, biotechnology, medical devices/diagnostics and/or CROs).
  • Preferred experience with advanced therapy medicinal products (ATMP) and/or regenerative medicine products
  • Preferred experience and expertise in one of the following areas: Cardiovascular medicine, Cardiovascular surgery, Nephrology, Transplantation
  • Demonstrated track record of presenting findings within peer-reviewed journals and at major scientific/medical conferences
  • Strong background in pharmacovigilance oversight, conducting clinical trials and medical device, biologic and/or pharmaceutical industry drug development process
  • Experience in scientific and clinical development for regulatory submissions
  • Experience in regulatory affairs and operations, regulatory filings, global strategies, and execution
  • Experience and understanding of leading and directing senior, experienced health care professionals, peers, and subordinates
  • Experience working with Operating Councils or Board of Directors

Bonus Points:

  • Excellent knowledge of ICH/GCP/FDA and other country specific regulations and guidelines for medical devices and/or pharmaceutical/biologic agents
  • Recognized by other clinicians or medical community as a strategic thinker or thought leader
  • Prior experience in interfacing with physicians/clinicians on an international basis would be preferred

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 3 Weeks’ Vacation
  • 5 Personal Floating Days
  • 8 Sick Days
  • 6 Company Holidays
  • Career Development and Training