GSK
Senior Director, Clinical Development
Senior Director, Clinical Development
Posted 1 week ago
LondonPermanentHybridFull-TimeLead
Posted 1 week ago
Description
Job Purpose
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Design & Development
Clinical & Regulatory Leadership
Safety Oversight & Governance
Collaboration & External Engagement
Accountabilities
Basic Qualifications
Preferred Qualifications
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 (including family medical history), military service or any basis prohibited under federal, state or local law.
- 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.
Basic Qualifications
- 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.
Preferred Qualifications
- 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.
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 (including family medical history), military service or any basis prohibited under federal, state or local law.
GSK
A global biopharma company uniting science, technology and talent to get ahead of disease
LondonPharmaceuticals1000+
GSK
Work on medicines and vaccines transforming millions of lives. Collaborate with 66,800 people across science and clinical innovation to tackle cancer, HIV and infectious diseases at a company ambitious for patients and accountable for impact.