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Sr. Director, Clinical Development

All Openings | Research Triangle Park, NC | Full Time

Job Description

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.  We are looking for additional colleagues to continue to build our expanding team.

Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

The Senior Director, Clinical Development, is responsible for the leadership and oversight of the clinical operations team, global clinical trials management and 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.

Primary Responsibilities:

  • Provide strategy, direction and oversight for the management of global clinical trials to include vendor selection, vendor management, day to day operational oversight of CRO partners and other clinical trial vendors
  • Manage external partners, consultants, vendors and external budgets to ensure timely and cost- effective implementation of the Clinical Development Plan
  • Develop and manage Clinical Development Budget including review and approval of contracts, work orders and invoices within grant of authority
  • Participate in review and development of protocols, Investigator Brochure (IB), Clinical Study Reports (CSR), Development Safety Update Report (DSUR), Development Plans to ensure alignment with strategic plans of the organization
  • Develop, monitor and effectively manage Key Performance Indicators (KPIs) to track the progress of the ongoing clinical studies as it relates to CRO and other vendor performance
  • Manage CROs, vendors and day-to-day activities associated with the conduct of clinical studies. This includes, but is not limited to, the following:
    • Participate in discussions on the strategy for operationalization of clinical studies and site selection
    • Review and approve study plans and other documents to ensure CRO and vendor compliance
    • Ensure appropriate training of team members (including CRO staff)
    • Develop and track clinical study budgets (planned versus actual)
    • Includes review and approval of invoices against contracts
    • Oversee IP distribution to investigative sites
    • Ensure that clinical studies are conducted in accordance with SOPs, GCPs, ICH guidelines, and all applicable regulations
    • Ensure that clinical studies are conducted in accordance with executed contracts and budgets
    • Be a key interface and resource for investigators (includes monitoring in the field as needed) and vendors
  • Identify need for, develop and/or review clinical SOPs as needed
  • Represent Humacyte at selected conferences and other meetings
  • Collaborate with Regulatory & Quality to ensure proactive compliance with appropriate regulations
  • Effectively influence key internal and external stakeholders regarding matters of significance related to clinical trial management and clinical deliverables utilizing data and knowledge of company strategy as related to clinical trial management
  • Provide all personnel management for clinical team direct reports to include, recruitment, retention, performance management, and career development
  • Other duties, as assigned

General Competencies:

  • Able to communicate effectively in English, both verbally and in writing
  • 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 collaborate effectively with others
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner
  • High degree of flexibility and adaptability
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Must be able to work as needed to meet tight deadlines and at peak periods
  • Self-motivated and organized critical thinker with solid interpersonal and business communication skills
  • Demonstrated ability to work in a cross functional team
  • Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
  • Always observe safety precautions and regulations in all areas where duties are performed. Responsible for reporting all safety hazards and potential unsafe working conditions
  • Represents the organization in a positive and professional manner
  • Reports to work on time and as scheduled

Special Competencies:

  • Excellent 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 development process
  • Ability to lead discussions with executive management team on strategy and policy issues

QUALIFICATIONS:

  • Bachelor's degree, required.  Master's degree, preferred.
  • At least 10 years PM/study management experience
  • Both sponsor (CRO oversight) and CRO experience highly desirable
  • Clinical background/experience preferable (e.g., nurse, clinical pharmacist, NP, PA)
  • Recent NDA or BLA experience, preferred
  • 5-7 years of progressively responsible people leadership experience

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 11 Paid Holidays
  • Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**