ViiV Healthcare (GSK) Medical Director, ViiV R&D Physician Center of Excellence
GSK
8 days ago
Remote friendly (Durham, NC)
United States
Clinical Research and Development
Medical Director (Medical Monitor) – R&D Physician Center of Excellence
Responsibilities
- Serve as Clinical Trial Director for Phase 1–4 trials; design study protocols and supplementary documentation (procedure manuals, analysis plans, protocol deviation plans).
- Provide medical governance to ensure clinical/operational excellence in study execution.
- Manage study conduct, enrollment strategies, and interpretation of clinical data.
- Manage safety events/toxicity concerns; train internal/external teams on protocol-defined safety parameters.
- Ensure trial-related inquiry and safety event documentation in the electronic Trial Master File.
- Partner with internal teams (virology, pharmacology, biostatistics, drug safety, regulatory affairs, discovery science) to design clinical studies.
- Collaborate with external investigators, consultants, IRBs/RECs, and community stakeholders for feasibility, conduct, and reporting.
- Assist with regulatory submissions (U.S. and international); respond to regulatory queries and present findings to internal governance groups.
- Foster teamwork in a matrix environment; lead/adapt in a fast-paced setting.
Required Qualifications
- Licensed Physician (MD or DO)
- Internal Medicine or Family Medicine residency training
- 3+ years expertise in Infectious Diseases (patient care or research)
- Drug development OR clinical trials experience
Preferred Qualifications
- Infectious Diseases fellowship (HIV) and/or extensive HIV clinical treatment/management experience
- Clinical trials expertise, including 2+ years in drug development and execution in HIV/infectious diseases
- Leadership in matrix environments; active medical license
- Exceptional communication with cross-functional/external stakeholders
Benefits
- Visit the GSK US Benefits Summary to learn about the comprehensive benefits program (ViiV employees receive GSK employee benefits options/plans).
Responsibilities
- Serve as Clinical Trial Director for Phase 1–4 trials; design study protocols and supplementary documentation (procedure manuals, analysis plans, protocol deviation plans).
- Provide medical governance to ensure clinical/operational excellence in study execution.
- Manage study conduct, enrollment strategies, and interpretation of clinical data.
- Manage safety events/toxicity concerns; train internal/external teams on protocol-defined safety parameters.
- Ensure trial-related inquiry and safety event documentation in the electronic Trial Master File.
- Partner with internal teams (virology, pharmacology, biostatistics, drug safety, regulatory affairs, discovery science) to design clinical studies.
- Collaborate with external investigators, consultants, IRBs/RECs, and community stakeholders for feasibility, conduct, and reporting.
- Assist with regulatory submissions (U.S. and international); respond to regulatory queries and present findings to internal governance groups.
- Foster teamwork in a matrix environment; lead/adapt in a fast-paced setting.
Required Qualifications
- Licensed Physician (MD or DO)
- Internal Medicine or Family Medicine residency training
- 3+ years expertise in Infectious Diseases (patient care or research)
- Drug development OR clinical trials experience
Preferred Qualifications
- Infectious Diseases fellowship (HIV) and/or extensive HIV clinical treatment/management experience
- Clinical trials expertise, including 2+ years in drug development and execution in HIV/infectious diseases
- Leadership in matrix environments; active medical license
- Exceptional communication with cross-functional/external stakeholders
Benefits
- Visit the GSK US Benefits Summary to learn about the comprehensive benefits program (ViiV employees receive GSK employee benefits options/plans).