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GSK

Develops medicines, vaccines, and consumer health

Clinical Development Medical Director - Cardiovascular

Biology & BiotechConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A medical degree is required.
  • Completion of formal postgraduate clinical training, clinical residency, or specialty training in Internal Medicine, Pathology, or another relevant area is required.
  • Demonstrated experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation is required.
  • Strong working knowledge of clinical development processes, including Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and global regulatory frameworks is required.
  • Ability to apply clinical judgment to support study design, patient safety, and real-time medical decision-making within a structured clinical development framework is required.
  • Experience operating effectively within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment is required.
  • Strong scientific communication skills, including the ability to translate clinical data into clear insights for internal and external audiences, are required.

Responsibilities

  • Support alignment of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the Clinical Development Plan (CDP), and develop sections of core regulatory documents.
  • Generate data and evidence to determine a target’s potential efficacy, safety profile, key areas of differentiation, and route to becoming a medicine with value to patients in the shortest possible timeframe.
  • Define and deliver the clinical pillars of the translational table.
  • Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism, and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP.
  • Establish and maintain relationships with program counterparts in Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs, and Statistics.
  • Contribute to implementation and embedding of strategic and organizational initiatives in Clinical Development.
  • Provide effective support and oversight of research and development evidence-generation strategy, plans, and activities to ensure patient safety and on-time, in-full study delivery.
  • Contribute to study-team discussions on indication planning and incorporate cross-disciplinary input to deliver early medicine profiles, target validation, translational plans, and candidate selection.
  • Design clinical development plans, study protocols, and associated documents across all phases of development, reflecting input from patients, evidence generation, regulators, payors, and pharmacovigilance.
  • Provide clinical expertise for regulatory interactions and documents, including briefing documents, presentations, and responses to questions for assigned studies and programs.
  • Provide medical monitoring and oversight of study-participant safety on behalf of the Sponsor during studies, together with the Pharmacovigilance Physician.
  • Ensure scientific integrity and overall study-subject safety through medical governance across the project.
  • Lead the Clinical Matrix Team (CMT) for a program and serve as the internal and external clinical point of contact for an asset indication or clinical study.
  • Lead end-to-end clinical development strategy for an early program and potentially contribute to later stages.
  • Serve as the primary clinical point of contact for an early-development investigational agent or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, clinical investigators, and relevant internal review boards.
  • Assist with clinical evaluation of business development opportunities.
  • Stay abreast of research advances, clinical-trial methodologies, the competitive environment, and regulatory developments in the relevant disease area.
  • Identify and highlight transformational opportunities for projects to offer significant patient benefit beyond existing approaches.
  • Gather and support integration of cross-disciplinary scientific, clinical, commercial, and regulatory input into clinical components of the Medicine Profile.
  • Contribute to solving study and clinical-development challenges.
  • Influence stakeholders at project, departmental, and inter-departmental levels.
  • Use new learning and digital tools to create innovative approaches to science and technical solutions.
  • Promote an environment in which others generate improvement ideas and proactively drive innovation.
  • Achieve outcomes by understanding others’ perspectives, building trust, tailoring communications to audiences, and using persuasive arguments to gain support.
  • Inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued and motivated.
  • Manage conflicts independently and negotiate mutually acceptable solutions.
  • Collaborate across the matrix, integrate cross-functional knowledge into decision-making, and balance team objectives with broader business goals.
  • Analyze, interpret, and critically evaluate data, information, and digital content to understand complex information, anticipate obstacles, and identify solutions.
  • Adapt to changing environments, analyze incomplete information, identify potential risks and implications, and make informed decisions.

Desired Qualifications

  • Completion of advanced specialty training, a fellowship, or a country-equivalent higher-level qualification leading to recognition as a medical specialist through formal certification, board certification, or a country-specific professional designation.
  • Experience in pharmaceutical or biotechnology clinical development across early-phase studies.
  • Clinical experience in a relevant specialty or therapeutic area, with direct exposure to clinical research or drug development in industry or postgraduate work.
  • Robust knowledge of cardiovascular research priorities, public health needs, competitor landscape, clinical-practice trends, and evolution of treatment guidelines.
  • Knowledge of and experience executing clinical or translational studies, including generating and analyzing human translational data and conducting preclinical biological experiments in relevant model systems.
  • Experience working with global regulatory agencies and managing global clinical trials in a relevant disease area.
  • Prior experience contributing to regulatory interactions, such as Investigational New Drug (IND) submissions, scientific advice, or New Drug Application (NDA)/Marketing Authorization Application (MAA) filings.
  • Demonstrated experience engaging with Key External Experts (KEEs), investigators, and scientific collaborators in disease areas.
  • Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards.
  • Experience contributing to IND/Clinical Trial Application (CTA), NDA, Biologics License Application (BLA), or MAA submissions.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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