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Director, Clinical Data Management

3 months ago

Durham, United States HUMACYTE GLOBAL INC Full time
Job DescriptionJob Description

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 in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, 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 has received an RMAT designation. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com



JOB SUMMARY:

The Director, Clinical Data Management will lead the clinical data management function with full accountability for Data Management (DM) activities and setting the direction for Clinical Data Management at Humacyte. The Director will collaborate with partner functions in Clinical Development Department (e.g., Clinical Operation, Clinical Research, Biometrics) and oversee the vendor DM counterparts and tasks including study set-up, capture, data cleaning, and delivery of clinical data. The ideal candidate has demonstrated expertise and leadership on DM activities to support clinical development, regulatory submissions, and inspections.

ESSENTIAL FUNCTIONS:

  • Responsible for all DM deliverables in multi-disciplinary interactions.
  • Oversee the design, build, testing, review and maintenance of clinical study database.
  • Serve as in house DM point of contact in all interactions with vendors and key stakeholders.
  • Lead cross-functional collaborations on external data transfer and data integration.
  • Lead and oversee ongoing data review, cleaning, lock, transfer, and close-out activities.
  • Develop standards and establish best practices for DM function.
  • Evaluate resource needs and help build the DM function at Humacyte.

EXPERIENCE & QUALIFICATIONS:

  • Bachelors required; masters preferred.
  • 10-15 years of relevant biopharma/CRO experience required; both sponsor and CRO experience highly desirable.
  • Recent submission and inspection experience preferred, vascular experience, highly preferred.
  • Broad and advanced knowledge of DM and relevant disciplines related to clinical development and clinical studies.
  • Project management abilities including delegation, flexible team management, organization, analytical evaluation, negotiation, and resource management.
  • Excellent knowledge of managing operational challenges including managing conflict, site EDC training, vendor oversight, database build, data review/cleaning process, etc.
  • Solid understanding of FDA, EMA, ICH and global regulations as well as CDISC and industry standards.
  • Excellent communication and interpersonal skills.
  • Demonstrated ability to work in a cross functional team.
  • 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
  • Must be able to work as needed to meet tight deadlines and at peak periods.
  • Self-motivated and organized critical thinker with excellent overall communication skills.

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 3rd 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.