Clinical Development Medical Director - Cardiovascular

About the role

GSK is seeking an experienced Medical Director, Clinical Development - Cardiovascular to join its Respiratory, Immunology & Inflammation Research Unit. The role provides clinical and scientific leadership to clinical and translational studies and programs, contributes to target assessment and validation, and helps build clinical development plans, real-world data and translational/biomarker capabilities. It is hybrid, with at least two days per week on site at the posted location (Stevenage initially, then Cambridge).

Key responsibilities

• Align translational and clinical plans and study designs with project strategies, and develop sections of core regulatory documents.
• Generate the data and evidence needed to assess a target's efficacy, safety profile and route to a medicine.
• Define and deliver the clinical pillars of the translational table, and set timelines, endpoints and Go/No Go criteria.
• Build relationships with Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs and Statistics.
• Oversee the R&D evidence generation strategy, study protocols and documents, and bring clinical expertise to regulatory interactions.
• Provide medical monitoring and oversight of participant safety, and hold medical governance across the project.
• Lead the Clinical Matrix Team for a program, act as clinical point of contact for an indication or study, and represent the team at early development meetings.
• Contribute to the Medicine Profile, stay up to date on research and regulatory developments, and identify opportunities that offer significant patient benefit.

Required profile

• Medical degree and completion of postgraduate clinical training, clinical residency or specialty training in Internal Medicine, Pathology or similar.
• Demonstrated experience in clinical trial conduct, including medical monitoring, safety review and clinical data interpretation.
• Experience in cross-functional matrix teams in a pharmaceutical, biotechnology or academic clinical trial environment.
• Preferred: advanced specialty training or board certification, early-phase clinical development experience, cardiovascular research knowledge, and experience with IND/CTA, NDA/BLA or MAA submissions.

Required skills

• Good Clinical Practice (GCP) and ICH guidelines, and global regulatory frameworks.
• Clinical development, drug regulatory affairs and scientific presentations.
• Preferred: experience with global regulatory agencies and clinical trials, and with Key External Experts and investigators.

What we offer

• Hybrid working model.
• Annual bonus and eligibility for a share-based long-term incentive program.
• Healthcare and other insurance, retirement benefits, paid holidays, vacation and parental/medical leave.