Executive Director, Clinical Development & Medical Affairs

Executive Director, Clinical Development & Medical AffairsThe 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 OperationsDevelop, Own and Execute the Clinical Development PlanLead the execution of post approval clinical studies for Trauma IndicationDesign 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 dossiersDevelop and guide the execution of the corporate medical affairs strategy across different indicationsCollaborate with External Thought Leaders, Humacyte Field Medical Affairs and Commercial as needed particularly for label expansion and life cycle management studies/initiativesProvide 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 expertRepresent Humacyte at selected Conferences, Advisory Boards, Regulatory interactions and other meetingsCollaborate with Regulatory & Quality to ensure proactive compliance with appropriate regulationsProvide all personnel management for team direct reports (as applicable) to include, recruitment, retention, performance management, and career developmentOther Duties as assigned.Experience & Qualifications:MD required7-10 years of relevant pharma experience, required. Vascular surgical experience preferredRecent NDA or BLA experience preferred5-7 years of progressively responsible people leadership experienceKnowledge of ICH/GCP/FDA and other country specific regulations and guidelines for medical devices and/or pharmaceutical/biologic agentsStrong background in conducting clinical trials and pharmaceutical industry drug/biologic development processMedical Affairs ExperienceAbility to lead discussions with executive management team on strategy and policy issuesExcellent 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 Options401k Plan with 4% Match and no Vesting ScheduleMedical, Vision and Dental PlansCompany Paid Long Term/Short Term DisabilityCompany Paid Life Insurance23 Days Paid Time Off (PTO)10 Company Designated Holidays + 2 Floating HolidaysPaid Parental Leave PoliciesPlease note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters.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.