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GSK

Develops medicines, vaccines, and consumer health

Director, Clinical Science - Oncology Clinical Development GYN

Clinical Research OperationsPosted on Nov 11
Full-timeHybrid

About the Job

Requirements

  • A bachelor's degree in life sciences or a related scientific discipline is required.
  • Experience in the pharmaceutical or biotechnology industry, or related clinical development experience, with a focus on oncology.
  • Experience in clinical development from early stage through regulatory submission, including study design, protocol authoring, and data review and interpretation.
  • Experience working within Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and global regulatory guidelines.
  • Experience authoring or contributing to clinical study proposals, protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and regulatory submissions.
  • Experience working within cross-functional matrix teams and contributing to clinical decision-making.
  • A proven track record of working with investigators, site staff, external experts, contract research organizations (CROs), and vendors.

Responsibilities

  • Provide scientific leadership across defined study-level activities, including protocol development, study design, data review, and interpretation, within the strategic direction set by the Clinical Development Lead (CDL).
  • Serve as a core member of the Clinical Matrix Team (CMT), ensuring scientific alignment across study objectives, timelines, and deliverables.
  • Provide scientific insight to the CDL and Senior Scientist to inform asset-level strategy, benefit–risk assessment, and programme-level decision-making.
  • Ensure the scientific quality and consistency of key clinical and regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, and submission materials.
  • Analyse and interpret data using scientific and clinical expertise, ensuring rigour, integrity, and relevance to the target patient population.
  • Engage with internal and external stakeholders, including investigators and Key External Experts, to support study execution and scientific exchange.
  • Contribute to a culture of scientific excellence, innovation, and continuous improvement within Oncology Clinical Development.
  • Provide scientific input into protocol development and study design, ensuring robustness, feasibility, and alignment with Clinical Development Plan-defined objectives and regulatory requirements.
  • Author or co-author key study documents, such as Clinical Study Proposals, and contribute to preparation and presentation at governance forums such as Protocol Review Boards.
  • Support study conduct by addressing scientific questions, ensuring data integrity, and maintaining alignment with protocol and regulatory standards.
  • Provide scientific input into study-level decisions related to protocol implementation and study conduct within the strategic framework defined by the CDL.
  • Present and support the scientific rationale and study design at Investigator Meetings and respond to scientific inquiries from study sites.
  • Support implementation of study-level Go/No-Go criteria aligned to the asset-level decision framework defined by the CDL.
  • Analyse and interpret clinical data to generate insights on safety, efficacy, and patient populations.
  • Integrate data from internal and external sources, including literature, competitor data, and emerging science, to inform study and programme understanding.
  • Provide scientific input into data review and interpretation activities in collaboration with Medical Directors and pharmacovigilance.
  • Translate study findings into clear scientific insights to inform programme progression and support CDL-led decision-making.
  • Contribute to development of clinical and regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, and submission materials.
  • Ensure scientific accuracy, consistency, and quality across study documentation.
  • Support preparation of regulatory submissions and responses to Health Authority queries.
  • Contribute to regulatory reporting requirements, including Development Safety Update Reports (DSURs) and Investigational New Drug Safety Reports (INDSRs), and ensure alignment with regulatory standards.
  • Serve as a core member of the CMT, partnering with Clinical Operations, Statistics, Safety, Regulatory, and Medical Affairs to support integrated study delivery.
  • Provide scientific expertise to cross-functional discussions, including integrated evidence planning and disease-area forums, as appropriate.
  • Participate in internal and external scientific interactions with investigators, Key External Experts, advisory boards, and collaborators.
  • Contribute to scientific communications, including publications, congress presentations, and study-related materials.
  • Identify scientific and operational risks at the study level and provide input into mitigation strategies.
  • Support and drive implementation of consistent ways of working and process improvements across the programme.
  • Participate in Oncology Clinical Development initiatives and workstreams to strengthen standards, processes, and capabilities.
  • Engage in ongoing development to deepen scientific expertise, expand disease-area knowledge, and build broader clinical development capabilities.
  • Work on-site at one of the posted locations at least two days per week, with remote work available on other days.

Desired Qualifications

  • An advanced degree, such as an MS, PhD, or PharmD, in life sciences or a related discipline.
  • Clinical development experience across multiple phases of development (Phase I–IV).
  • GYN Oncology clinical development experience.
  • Experience presenting or preparing materials for Protocol Review Boards, governance meetings, or scientific forums.
  • Knowledge of regulatory requirements to support registration, including experience contributing to IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, or Advisory Committee (AdCom) 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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