ViiV Healthcare (GSK) Medical Director, ViiV R&D Physician Center of Excellence

Medical Director is a critical role within the R&D Physician Center of Excellence, primarily serving as a Medical Monitor (MM) for Phase 1-4 clinical trials. The role involves cross functional collaboration with internal leaders and external stakeholders, contributing directly to the development of groundbreaking HIV treatment and prevention strategies.

Responsibilities

• Clinical Trial Management and Oversight: Serve as Clinical Trial Director for Phase 1-4 trials, designing study protocols and supplemental documentation, including study procedures manuals, analysis plans, and protocol deviation plans. Provide medical governance, ensuring clinical and operational excellence in study execution. Manage study conduct, enrollment strategies, and interpretation of clinical data.
• Safety and Medical Expertise: Provide expertise in managing safety events and toxicity concerns. Train internal and external teams on protocol-defined safety parameters. Ensure comprehensive documentation of trial-related inquiries and safety events in the electronic Trial Master File.
• Cross Functional Collaboration: Partner with internal teams in virology, pharmacology, biostatistics, drug safety, regulatory affairs, and discovery science to design efficient clinical studies. Collaborate with external investigators, consultants, institutional review boards (IRBs)/research ethics committees, and community stakeholders for trial feasibility, conduct, and reporting.
• Regulatory Support and Reporting: Assist in developing submissions for regulatory bodies (U.S. and international) during and post study phases. Prepare responses to regulatory queries and present clinical trial findings to internal governance groups.
• Team Leadership and Organizational Growth: Foster strong professional relationships and teamwork within a matrix environment to drive project success. Thrive in a fast paced, dynamic setting while demonstrating leadership and adaptability. Contribute to organizational growth and innovation, supporting the mission of global impact.

Qualifications

• Licensed Physician (MD or DO)
• Completion of Internal Medicine or Family Medicine residency training
• 3+ years of demonstrated expertise in Infectious Diseases, either patient care or research
• Drug development or clinical trials experience

Preferred Qualifications

• Either clinical fellowship in Infectious Diseases, in HIV and/or extensive experience in HIV clinical treatment and management
• Expertise in conducting clinical trials, including 2+ years in drug development and execution of trials in HIV or infectious diseases
• Proven leadership experience in matrix environments and team collaborations
• Active medical license or equivalent qualification to practice medicine
• Exceptional communication skills with the ability to foster strong professional relationships across functional areas and with external stakeholders

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