Key skills
Leadership
About this role
Role Overview
- Provide scientific leadership, direction, and contribution to the strategy employed in early clinical development programs.
- Contribute to the study team in the design and development of high quality, timely studies.
- Contributes to the medical governance and regulatory reporting at the study level.
- Liaises with Clinical Pharmacology, Medical, Commercial, and Asset Leads to ensure study evaluates key aspects of the Asset Product Profile.
- Contributes to the scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with the protocols.
- Works closely with study physician(s) to help monitor safety and benefit/risk for studies.
- Contributes to quality assurance and inspection readiness activities.
Requirements
- B.S., Masters, Ph.D., Pharm.D., or MD with 3 plus years of recent clinical drug development experience.
- 3 plus years contributing to a team, 3rd parties, academic partners, and subcontracted organizations.
- Experience with managing multiple programs concurrently.
- Prior experience in early clinical development (Phase 1 and 2 studies) or late stage clinical development (Phase 3 studies) preferred.
- Prior HIV drug development experience strongly preferred and antiviral, or infectious disease therapeutic area.
- Ability to respond with confidence to complex study questions using sound judgment and interpretation of applicable data.
- Ability to communicate complex scientific information concisely and clearly.
- Ability to influence (internally and externally) without formal authority.
Benefits
- ViiV offers US employees receive the same benefits options and plans as GSK employees.