Fellowship in Industry Program - Gilead

Activities at Gilead

The fellow, with guidance from the program mentors, will support research and development projects which will include some or all of the following:

• Design and implement a clinical pharmacology and/or modeling and simulation research project(s).
• Present the results of the research project(s) at Gilead, University of the Pacific, a local and/or national scientific meeting and/or publish them in a peer-reviewed journal.
• Serve as a Clinical Pharmacology lead for a healthy volunteer study for a small and/or large molecule project, such as food effect, drug-drug interaction, formulation bridging or bioequivalence.
• Serve as a Clinical Pharmacology representative on cross-functional project sub-teams (including clinicians, pharmacologists, biomarker experts, biostatisticians, regulatory experts), facilitating discussions of clinical pharmacology-related issues.
• Develop clinical pharmacology plans for small and/or large molecule projects and obtain buy-in from the project team.
• Author clinical pharmacology sections of documents (e.g., clinical trial protocols, investigator brochures, clinical study reports, health authority
• pre-meeting packages, NDAs, BLAs).

The fellow will:

• Develop hands-on modeling and simulation skills (e.g., noncompartmental, compartmental, PK/PD, and population PK modeling using softwares such as Phoenix/NonMEM, Monlix).
• Develop an understanding of ICH, FDA, EMA, PMDA and other relevant clinical pharmacology guidances and apply them in their work.
• Develop an understanding of Phase 1-4 drug development in different therapeutic areas.

Fellowship Program Dates

The fellowship begins July 1, 2024 and ends June 30, 2026.

This one-year Clinical Operations fellowship provides in-depth exposure to Clinical Development and understanding the basic principles of clinical operations. The fellow will function as a member of Gilead’s Clinical Operations team which is responsible for the execution of all Phase 1-4 Gilead clinical trials across all therapeutic areas world wide. In partnership with a cross-functional team, the fellow will ensure that all clinical trial activities are performed in accordance with applicable SOPs, company policies, regulatory guidelines, and help deliver high quality clinical data to support global registration and commercialization of new medicines.

Activities at Gilead

• The fellow will function as a clinical trial management associate and support clinical trial managers and clinical program managers on the following activities:
• Maintain internal Clinical Operations databases and document repositories.
• May serve as the key operational contact for Gilead studies, providing assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
• May serve as the key operational contact and coordinate with vendors such as central lab, IVRS for study implementation.
• May assist in set up, organization and maintenance of clinical study documentation, such as trial master fies, including preparation for internal/external audits, regulatory inspections, final reconciliation
• and archival.
• May assist in preparation and development of protocols, informed consents, clinical study reports, monitoring plans and other study related plans.
• May lead cross-functional meetings to drive study timelines and support decision making by clinical development team.
• May assist in preparation of study training meetings of study monitors, investigators and site staff.
• May assist in study vendor budget review, contract finalization, invoice approval and budget reconciliation.

Fellowship Program Dates

The fellowship begins July 1, 2023 and ends June 30, 2024.