ViiV Healthcare (GSK) Senior Director, Clinical Development

GSK•Branford, CT

1d•Hybrid

About The Position

ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic. We are aware of how much is at stake for those affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV isn’t just somewhere to work – it’s a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference. While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities. As the Senior Medical Director, you will play a pivotal role in advancing our mission to leave no patient behind by ensuring clinical excellence in early development programs (with a focus on long-acting medicines) and providing medical governance for Phase 1–4 studies. You will work in a fast-paced, diverse, inclusive, and high-performing team that is dedicated to delivering breakthroughs in HIV care. This role will be based out of Durham, NC or Branford, CT or London & is eligible for a relocation package. Job Purpose • Provide medical leadership and strategic oversight for clinical development and medical governance associated with early stage studies, ensuring the highest standards of patient safety, data integrity, and scientific excellence. • Collaborate closely with internal stakeholders (including virology, pharmacology, biostatistics, and discovery science teams) as well as external partners (academic institutions, research collaboratives, and regulatory bodies) to design, execute, and interpret clinical studies. • Ensure that all study protocols, clinical study reports, and supplementary documents are developed and executed to support the assessment of a medicine’s potential efficacy, safety profile, and overall value to patients. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Design & Development • Lead the design and delivery of early development plans alongside executive leadership, confirming the data necessary to support the development of multiple early‐stage compounds. • Contribute to the development of study protocols, supplementary documents (e.g., study procedures manuals, reporting and analysis plans, protocol deviation management plans), and responses to regulatory queries. Clinical & Regulatory Leadership • Provide medical perspective on overall study conduct, procedures, and safety event management throughout the clinical trial lifecycle (from Phase 1–4). • Ensure that clinical input is accurately reflected in regulatory documents through the study lifecycle, including during development and post‐approval periods. • Participate in the preparation of answers to local IRB/Ethics Review Committee inquiries and ensure that all protocol-related documentation is complete and filed in the study TMF as required. Safety Oversight & Governance • Evaluate and synthesize safety event reports—including serious adverse events, adverse events, and laboratory values of concern—and escalate findings in a timely manner. • Present synthesized safety evaluations to relevant oversight boards and communicate their output to all stakeholders. • Provide training on protocol-defined safety parameters and toxicity management to both internal and external study team members. Collaboration & External Engagement • Work with Clinical Scientific Leaders to build and maintain external expert networks and ensure ethical and effective study delivery. • Liaise with collaborator study teams, investigators, and regulatory bodies to address any medical issues, concerns, or protocol inquiries that arise during feasibility assessments and study execution. Accountabilities • Overall accountability for clinical development activities at the project level, including the interpretation of data from various functions that may impact safety and efficacy. • Responsible for ensuring that the clinical activities within the project demonstrate a medicine’s potential efficacy, safety profile, reimbursability, and value in a timely manner. • Accountable for medical governance across all early stage studies, ensuring scientific integrity and the safety of study subjects, and for the review/approval of key study documents (e.g., protocols, informed consent forms). • Manage electronic protocol inquiries, site interactions (inclusive of safety events), and ensure proper documentation and filing in the study TMF.

Requirements

A qualified physician (MD, DO) with a clinical fellowship in Infectious Diseases OR substantial experience in clinical development and/or clinical trials execution in Infectious Diseases.
5+ years of experience in drug development or community clinical trials, with hands-on experience from conceptual study design through data analysis and publication.
Experience in early drug development, in late-stage drug development to include familiarity with discovery processes, toxicology, drug metabolism, pharmacokinetics, IND enabling study requirements, virology (including resistance), biometrics and data management, and clinical pharmacology.

Nice To Haves

MD/PhD or equivalent advanced degree.
Demonstrated effective communication skills with an ability to build and maintain 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 a passion for innovation in treatment and prevention approaches.
Sound commercial and financial acumen, including budgeting and forecasting as it relates to clinical development activities.

Responsibilities

Provide medical leadership and strategic oversight for clinical development and medical governance associated with early stage studies, ensuring the highest standards of patient safety, data integrity, and scientific excellence.
Collaborate closely with internal stakeholders (including virology, pharmacology, biostatistics, and discovery science teams) as well as external partners (academic institutions, research collaboratives, and regulatory bodies) to design, execute, and interpret clinical studies.
Ensure that all study protocols, clinical study reports, and supplementary documents are developed and executed to support the assessment of a medicine’s potential efficacy, safety profile, and overall value to patients.
Lead the design and delivery of early development plans alongside executive leadership, confirming the data necessary to support the development of multiple early‐stage compounds.
Contribute to the development of study protocols, supplementary documents (e.g., study procedures manuals, reporting and analysis plans, protocol deviation management plans), and responses to regulatory queries.
Provide medical perspective on overall study conduct, procedures, and safety event management throughout the clinical trial lifecycle (from Phase 1–4).
Ensure that clinical input is accurately reflected in regulatory documents through the study lifecycle, including during development and post‐approval periods.
Participate in the preparation of answers to local IRB/Ethics Review Committee inquiries and ensure that all protocol-related documentation is complete and filed in the study TMF as required.
Evaluate and synthesize safety event reports—including serious adverse events, adverse events, and laboratory values of concern—and escalate findings in a timely manner.
Present synthesized safety evaluations to relevant oversight boards and communicate their output to all stakeholders.
Provide training on protocol-defined safety parameters and toxicity management to both internal and external study team members.
Work with Clinical Scientific Leaders to build and maintain external expert networks and ensure ethical and effective study delivery.
Liaise with collaborator study teams, investigators, and regulatory bodies to address any medical issues, concerns, or protocol inquiries that arise during feasibility assessments and study execution.
Overall accountability for clinical development activities at the project level, including the interpretation of data from various functions that may impact safety and efficacy.
Responsible for ensuring that the clinical activities within the project demonstrate a medicine’s potential efficacy, safety profile, reimbursability, and value in a timely manner.
Accountable for medical governance across all early stage studies, ensuring scientific integrity and the safety of study subjects, and for the review/approval of key study documents (e.g., protocols, informed consent forms).
Manage electronic protocol inquiries, site interactions (inclusive of safety events), and ensure proper documentation and filing in the study TMF.