ViiV Healthcare (GSK) Medical Director, ViiV R&D Physician Center of Excellence
GSK
8 days ago
Remote friendly (Branford, CT)
United States
Clinical Research and Development
Medical Director (Medical Monitor) — Phase 1–4 clinical trials
Responsibilities:
- Serve as Clinical Trial Director for Phase 1–4 trials; design study protocols and documentation (procedures manuals, analysis plans, protocol deviation plans).
- Provide medical governance to ensure clinical/operational excellence; manage study conduct, enrollment strategies, and interpretation of clinical data.
- Manage safety events and toxicity concerns; train internal/external teams on protocol-defined safety parameters; document inquiries and safety events in the electronic Trial Master File.
- Partner with virology, pharmacology, biostatistics, drug safety, regulatory affairs, and discovery science to design efficient studies.
- Collaborate with external investigators, consultants, IRBs/RECs, and community stakeholders for feasibility, conduct, and reporting.
- Assist with U.S. and international regulatory submissions during and post-study; respond to regulatory queries and present findings to internal governance.
- Foster teamwork in a matrix environment and demonstrate leadership/adaptability.
Qualifications (Required):
- Licensed Physician (MD or DO)
- Completion of Internal Medicine or Family Medicine residency
- 3+ years infectious diseases expertise (patient care or research)
- Drug development OR clinical trials experience
Preferred:
- Infectious Diseases fellowship (HIV) and/or extensive HIV clinical treatment/management experience
- Clinical trial expertise (2+ years drug development and HIV/infectious disease trial execution)
- Leadership in matrix environments; active medical license
- Exceptional communication skills with internal and external stakeholders
Responsibilities:
- Serve as Clinical Trial Director for Phase 1–4 trials; design study protocols and documentation (procedures manuals, analysis plans, protocol deviation plans).
- Provide medical governance to ensure clinical/operational excellence; manage study conduct, enrollment strategies, and interpretation of clinical data.
- Manage safety events and toxicity concerns; train internal/external teams on protocol-defined safety parameters; document inquiries and safety events in the electronic Trial Master File.
- Partner with virology, pharmacology, biostatistics, drug safety, regulatory affairs, and discovery science to design efficient studies.
- Collaborate with external investigators, consultants, IRBs/RECs, and community stakeholders for feasibility, conduct, and reporting.
- Assist with U.S. and international regulatory submissions during and post-study; respond to regulatory queries and present findings to internal governance.
- Foster teamwork in a matrix environment and demonstrate leadership/adaptability.
Qualifications (Required):
- Licensed Physician (MD or DO)
- Completion of Internal Medicine or Family Medicine residency
- 3+ years infectious diseases expertise (patient care or research)
- Drug development OR clinical trials experience
Preferred:
- Infectious Diseases fellowship (HIV) and/or extensive HIV clinical treatment/management experience
- Clinical trial expertise (2+ years drug development and HIV/infectious disease trial execution)
- Leadership in matrix environments; active medical license
- Exceptional communication skills with internal and external stakeholders