SCIENTIFIC PROGRAM LEADER I

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational Summary

The Program Leader is responsible for managing a complex research pathway focused on basic science and translational research, dedicated to vaccine and/or therapeutic design, pre-clinical studies across a number of different models, manufacturing vaccines and therapeutics, and/or Phase 1/2/3/4 clinical trials and challenge studies by working with leadership in the coordination, evaluation, and scientific management of large research programs. The Program Leader serves as a scientific resource for investigators with management of technical pre- award activities related to the technical submission of grants, contracts and other funding opportunities and post award management. The Scientific Program Leaders will collaborate with the sponsors and research teams to present technical updates to advance the project towards the goal.

Work Performed

• Program Leaders are tasked with managing programs focused on Basic Science dedicated to vaccine and/or therapeutic design, pre-clinical studies across a number of different models, manufacturing, and/or Phase 1/2/3/4 clinical trials and challenge studies. Specific duties are defined below:
• Develop, coordinate, and implement scientific research, financial, and administrative strategies essential to the successful management of translational research projects conducted by principal investigator(s); perform a variety of duties involved in the organization, documentation and compilation of basic research, pre-clinical, manufacturing, and clinical data.
• Assist investigators with developing scientific 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:
• Clinical trial protocol development and trial summary reports Study plan development and study design Scientific concept development for future funding Draft complex scientific presentations summarizing work for Scientific Advisory Board meetings Grant and Contract Technical Proposal development
• 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 finance administrators 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

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.