ViiV Healthcare (GSK) Clinical Development Manager

ViiV Healthcare is a global specialty HIV company dedicated to researching and delivering new medicines for people living with or at risk of HIV.

Role Overview

The Manager, Clinical Development provides scientific leadership and direction for ViiV Healthcare clinical development programs, contributing to study design, development, and reporting.

Responsibilities

• Contribute to ViiV Healthcare early- and/or late-stage clinical development programs.
• Lead the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfills strategic objectives of clinical development.
• Liaise with Operations, Clinical Pharmacology, Medical, Regulatory, and Commercial Leads to ensure studies evaluate key aspects of the Asset Product Profile critical to product differentiation and reimbursement where possible.
• Provide scientific oversight of clinical studies, ensuring data collection and analysis plans align with protocols and allow intended scientific interpretation of study data and results.
• Partner with study team to ensure that all regulatory reporting requirements are met.
• Collaborate with physicians and other study team members and stakeholders to enable appropriate review of safety data, assist in identification of safety review committee members, and prepare interim safety review charter documents.
• Work closely with study physician(s) to monitor safety and benefit/risk for studies.
• Work within the study team to create evidence generation and scientific outputs, including content of investigator meetings, clinical study reports, preparation of study results for scientific meetings and congresses, external journal publications, regulatory documents, and other relevant study documents.
• Partner with clinical operations colleagues to ensure optimal delivery of studies while maintaining close collaborations with other functions supporting the study.
• Contribute to quality assurance and inspection readiness activities.

Required Qualifications

• B.S., M.S., Ph.D., Pharm.D., or M.D. with 3+ years of recent clinical drug development experience in a pharmaceutical industry or CRO environment, contributing to scientific aspects of clinical programs and regulatory submissions.
• Prior drug development experience in HIV, infectious diseases, or other relevant therapeutic area.
• Experience writing study protocols, informed consent forms, and clinical study reports.
• Experience reviewing and interpreting clinical and scientific data.
• 3+ years contributing to a cross-functional team, including internal and external partners (e.g., 3rd parties, academic partners, subcontracted organizations).

Preferred Qualifications

• Prior HIV or antiviral drug development experience strongly preferred.
• 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.
• Experience managing multiple programs concurrently.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, military service, or any basis prohibited under federal, state or local law.