ViiV Healthcare (GSK) Manager, Clinical Development

Role Summary

The core purpose of the Manager, Clinical Development is to provide scientific leadership, direction, and contribution to the strategy employed in ViiV Healthcare early clinical development programs. This role includes contribution to the study team in the design and development of high quality, timely studies (end to end from Commit to Study to reporting and publication). Contributes to the medical governance and regulatory reporting at the study level by collaborating with operations colleagues to ensure accuracy, quality, and timeliness of study results.

Responsibilities

• Contributes to ViiV Healthcare early and late stage clinical development programs.
• Contributes to the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfills strategic objective of clinical development
• Liaises with Clinical Pharmacology, Medical, Commercial, and Asset Leads to help ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possible.
• Contributes to the scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with the protocols, thereby allowing for intended scientific interpretation of study data and results.
• Partners with operations colleagues and matrix study team that all regulatory reporting requirements are met.
• Co-ordinates with physicians and other study team members and stakeholders to enable appropriate review of safety data. May assist in identification of safety review committee members and preparation of interim safety review charter document. Works closely with study physician(s) to help monitor safety and benefit/risk for studies.
• Works within the matrix team to help to create evidence generation and scientific outputs including content of investigator meeting, clinical study report, preparation of study results for scientific meetings, congresses, and external journal publications, preparation of regulatory documents, and other relevant study documents.
• Partners with clinical operations colleagues to help ensure optimal delivery of study while maintaining close collaborations with other functions supporting the study.
• Contributes to quality assurance and inspection readiness activities

Qualifications

• Required: B.S., Masters, Ph.D., Pharm.D., or MD with 3 plus years of recent clinical drug development experience contributing to the scientific aspects of clinical program(s) and regulatory submission(s).
• Required: 3 plus years contributing to a team, 3rd parties, academic partners, and subcontracted organizations.
• Required: Experience with managing multiple programs concurrently
• Preferred: 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
• Preferred: Ability to respond with confidence to complex study questions using sound judgment and interpretation of applicable data
• Preferred: Ability to communicate complex scientific information concisely and clearly
• Preferred: Ability to influence (internally and externally) without formal authority