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Scientific Program Leader I

Work Arrangement: 
Requisition Number:  178913
Regular or Temporary:  Regular
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER
Date:  Jan 31, 2023

This Position is Fully Grant Funded

 

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

TOXICOLOGY STUDY PROGRAM LEADER I

DUKE HUMAN VACCINE INSTITUTE

Occupational Summary

The Duke Human Vaccine Institute (DHVI) is a large, interdisciplinary organization with a goal to develop vaccines and therapeutics for HIV, Influenza, SARS-CoV-2, and other emerging infections. Moreover, the DHVI is one of the few academic institutions in the country that spans the full translational pipeline of Immunogen Design, Pre-Clinical Work, GMP Manufacturing, and Clinical Trials. The Program Leader is responsible for managing this complex research pathway by working with the DHVI leadership in the coordination, evaluation, and scientific management of large research programs. The Program Leader serves as a resource for DHVI investigators with management of pre-award activities related to the submission of grants, contracts and other funding opportunities and post award management of research programs within the DHVI.

Work Performed

Program Leaders are tasked with managing programs focused on basic science dedicated to vaccine and therapeutic design, pre-clinical studies across a number of different models (mouse, ferret, NHP, etc.), manufacturing and vaccines and therapeutics, and/or Phase 1/2/3/4 clinical trials and challenge studies. Specific duties for the toxicology study program leader are defined below:

  • Develop, coordinate, and implement scientific research, financial, and administrative strategies essential to the successful management of toxicology studies conducted by principal investigator(s) at the Duke Human Vaccine Institute in support of GMP manufacturing efforts.
  • Assist investigators with developing toxicology study strategies to achieve programmatic goals and implement scientific decision-making processes. Evaluate project effectiveness, develop risk management plans and provide warnings of serious deviations or variations that may compromise programmatic deliverables. Specific scientific strategies and processes include, but are not limited to, the following:
    • Collect toxicology study proposals from CROs
    • Evaluate study proposal design and costs and lead effort in CRO selection
    • Coordinate feedback and review with project investigators and sponsors
    • Toxicology study protocol development and study oversight
    • Coordinate shipment of material to CROs for study implementation
    • Manage conduct of assays in support of toxicology study both in-house and at CROs
    • Maintain study timelines for all DHVI-supported toxicology studies
    • Review draft and final study reports
    • Assist Regulatory Affairs Scientist with incorporation of toxicology study data into the IND package and clinical protocol, when appropriate
  • Participate and assist Program Management Leadership and Principal Investigators with the development and final negotiation of program budgets and program statements of work.
  • Collaborate with DHVI finance administrators and program leaders to track and project spending and report financial highlights to the primary investigators.
  • Proactively identify changes in work scope and ensure appropriate planning measures are taken with internal and external stakeholders to reassess, renegotiate, forecast, and amend scope of work responsibilities, proposals, staffing levels, resources, and budgets.
  • Plan, lead, and facilitate both regular cross-functional project team meetings and external meetings with sponsors and collaborators.  
  • The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

 

Required Qualifications at this Level

  • Education/Training: Completion of a Bachelor's degree in basic science, public health, clinical research or other related scientific field.
  • Experience: Four years of program management and/or research experience. Experience in Biotech/Biopharma/Clinical Trials/GMP is strongly preferred. Additional training in project management or related training desired. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

 

Preferred Qualifications

  • Education: Graduate degree strongly preferred
    • Completion of a Ph.D. or M.D. in basic science, public health, clinical research or other related scientific field with one additional years of program management and/or research experience required. OR
    • Completion of a Master’s degree in basic science, public health, clinical research or other related scientific field with two additional years of program management and/or research experience required. OR
    • Completion of a Bachelor’s degree in basic science, public health, clinical research or other related scientific field with four additional years of program management and/or research experience
  • Experience: Experience in Biotech/Biopharma/Clinical Trials is strongly preferred. Additional training in project management or related training desired.

 

 

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 


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