ViiV Healthcare (GSK) Senior Director, Clinical Development

ViiV Healthcare is a global specialty HIV company focused on researching and delivering new medicines for people living with or at risk of HIV. Our mission is to deliver breakthroughs in treatment, care solutions and community programs and to advance the goal of eradicating HIV/AIDS.

Job Purpose

Provide medical leadership and strategic oversight for clinical development and medical governance associated with early stage studies. Collaborate closely with virology, pharmacology, biostatistics, discovery science internal teams and external partners to design, execute and interpret clinical studies. Ensure all study protocols, reports and supplementary documents support the assessment of a medicine’s efficacy, safety profile and overall value to patients.

Design & Development

Lead the design and delivery of early development plans alongside executive leadership, confirming data to support development of multiple early‑stage compounds. Contribute to the development of study protocols, supplementary documents and responses to regulatory queries.

Clinical & Regulatory Leadership

Provide medical perspective on study conduct, procedures, and safety event management throughout the clinical trial lifecycle (Phase 1‑4). Ensure clinical input is accurately reflected in regulatory documents through the study lifecycle. Prepare answers to local IRB/Ethics Review Committee inquiries and file protocol‑related documentation in the TMF.

Safety Oversight & Governance

Evaluate and synthesize safety event reports, including serious adverse events, adverse events and laboratory values, and cascade findings promptly. Present synthesized safety evaluations to oversight boards and communicate outcomes to stakeholders. Provide training on protocol‑defined safety parameters and toxicity management.

Collaboration & External Engagement

Work with Clinical Scientific Leaders to build and maintain external expert networks for ethical and effective study delivery. Liaise with collaborator study teams, investigators and regulatory bodies to address medical issues, concerns or protocol inquiries during feasibility assessments and study execution.

Accountabilities

Overall accountability for clinical development activities at the project level. Ensure that clinical activities demonstrate medicine’s potential efficacy, safety profile, reimbursability and value in a timely manner. Accountable for medical governance across all early‑stage studies and for review/approval of key study documents. Manage electronic protocol inquiries, site interactions and documentation filing in the TMF.

Basic Qualifications

Qualified physician (MD or DO) with an infectious diseases fellowship or substantial experience in clinical development or trials execution in infectious diseases. Minimum 5 years of experience in drug development or community clinical trials, with hands‑on experience from study design through data analysis and publication. Experience in early and late‑stage drug development, including discovery processes, toxicology, drug metabolism, pharmacokinetics, IND enabling studies, virology (including resistance), biometrics, data management and clinical pharmacology.

Preferred Qualifications

MD or PhD or equivalent advanced degree. Demonstrated effective communication skills and ability to build strong interpersonal relationships in a matrix environment. Proven leadership experience translating strategy into action, motivating multidisciplinary teams and managing performance in a fast‑paced setting. Expertise in HIV drug development and passion for innovation in treatment and prevention. Sound commercial and financial acumen including budgeting and forecasting for clinical development activities.

ViiV Healthcare – Our Culture & Values

• Patient Focus – always putting the needs of those living with HIV first.
• Transparency, Respect and Integrity – maintaining open communication, mutual respect and high ethical standards.
• Courage and Accountability – making agile, evidence‑based decisions and taking responsibility for outcomes.
• Development and Teamwork – investing in team growth and building collaborative, impact‑driven partnerships.

All ViiV employees receive the same benefits options and plans as GSK employees. Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program. ViiV is an Equal Opportunity Employer. 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 other protected category. ViiV does not accept referrals from employment businesses or agencies unless prior written authorization has been obtained. Contact us at usrecruitment.adjustments@gsk.com for assistance with accommodations.