SCIENTIFIC PROGRAM LEADER I

This Position is Grant Funded, This is a term limited position of one year. The funds will expire in August 2025.

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

SCIENTIFIC 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 this position are defined below:

Scientific Program Leader I

The Scientific Program Leader will be responsible for working with the leadership of various labs in the coordination, evaluation, and scientific management of post award activities for large research programs, and serve as a resource with management of pre-award activities related to the submission of grants, and post award management of research programs within the DHVI. In particular, this Scientific Program Leader will work lead PIs, and other program management team members, in Duke University School of Medicine and DHVI to ensure successful programmatic support for nonhuman primate studies on the COVID P01, CHAVD, IPCAVD3, and/or the CIAVCR and other NIH-funded grants.

Project management:

• Assist PI with drafting annual reports, including research reports, statements of work, budgets, project timelines, and other required documents that are related to preclinical assay data.
• Maintain accurate financial projections as nonhuman primate study workups evolve, liaise with program team and financial team to share projections and stay within budget. Responsible for setting up all RSSAs and POs required. Reviews and signs off on all invoices related to nonhuman primate studies prior to payment from Duke.
• Act as an NHP animal study coordinator. Collaborate with research investigators and program management team to coordinate, manage, track, and plan the work up of NHP vaccination studies to support NIH funded grants, as well as multiple research programs across DHVI.
• Manage and maintain pre-clinical and clinical specimen database for large animal studies and human cohorts within the DHVI repository. Manage the specimen database, communicating with DHVI IT, DHVI AU, DHVI legal, DHVI Regulatory Compliance, and other departments, as needed. Responsible for working with the accessioning unit to request and pull specific samples to send to laboratories for assays.
• Evaluate and interpret collected assay data and prepare reports and analyses setting forth progress, adverse trends and appropriate recommendations or conclusions. Confer with principal investigator in developing plans for research projects and to discuss the interpretation of results and the preparation of scientific manuscripts for publication. Lead meetings as needed to drive this process.
• Assist in developing, coordinating, and overseeing the Memorandums of Understanding (MOUs) for all subcontracting institutions funded for NHP studies for compliance with Animal Research (IACUC).
• Act as a back up to work with primate centers on IACUC amendments to maintain compliance with Duke and Federal regulations.
• Work with the DHVI NHP studies team to plan and conduct meetings with investigators and programmatic staff to assess resource/financial needs that are necessary to implement/conduct/monitor current and planned NHP protocols assay workups.
• Perform any other assignments deemed necessary by the Principal Investigator or Program Management Leadership.

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.

1. 1. 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
   2. 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
   3. 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.

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.

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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.