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. The current effort for this position will focus on the scientific management of projects related to external quality assurance. A description of the work to be performed (scientific project management, scientific writing, and communication) is summarized below.

Work Performed

Scientific Project Management:

Assist investigators with developing scientific strategies to achieve programmatic goals and implement scientific decision-making processes. Scientific strategies include:

• 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

Evaluate project effectiveness, develop risk management plans and provide warnings of serious deviations or variations that may compromise programmatic deliverables.

Make operational and project decisions that have an impact on the successful achievement of project strategies.

Develop and define project goals and monitor and evaluate project effectiveness using qualitative and quantitative tools and recommend and implement modifications to improve effectiveness and meet project milestones.

Manage and lead meetings to discuss the scientific progress and future directions of programs.

Develop project management plans using Gantt charts.

Participate and assist Program Management Leadership and Principal Investigators with the development and final negotiation of program budgets and program statements of work.

Perform assignments deemed necessary by the Principal Investigator or Program Management Leadership.

Scientific Writing:

Manuscripts, Contract Proposals, Quality Assurance Site Reporting, and NIH Contract reporting

• Assist with collecting, assembling, and summarizing scientific and clinical data in reports/presentations. Collaborate with statistical team and project manager to develop study and analysis plan for data.
• Assist with drafting project proposals, including operational requirements, pricing and schedules for projects.
• Ensure contract reporting requirements are completed and submitted in accordance with the deadlines for each program.
• Draft reports for proficiency testing outcomes including site specific reports and summary reports for the NIH. 

Communication:

Serve as primary liaison with regulatory/compliance offices and departments at DHVI to coordinate projects to accomplish program objectives; interface with external organizations as appropriate to ensure cooperative efforts, positive progress, and project success.

Assist with logistics of specimen transfers and shipping (i.e. MTA, import permits, commercial invoices etc.)

Plan, lead, and facilitate regular cross-functional project team meetings.

Ensure required project data and information is regularly communicated to the project teams; generate and issue regular internal and external project reports.

Coordinate conference calls and meetings with project sponsors and collaborators. Take and distribute detailed minutes from calls and meetings for review and modify minutes based on comment.

Required Qualifications at this Level

Education/Training:

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.
4. Graduate Degree strongly preferred.

Experience:

A background in Virology or Immunology is strongly preferred. Additional training in Project Management or related training is desired.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Minimum Qualifications

Education

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

Degrees, Licensures, Certifications

Completion of a Bachelor's degree in basic science, public health, clinical research or other related scientific field.

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