Scientific Program Leader I

This Position is Fully Grant Funded

School of Medicine:

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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.

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