Medical Director, Oncology Clinical Development - GU

Description

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
 

Cancer is unrelenting, but so are we. At GSK, we are committed to transforming outcomes for people with cancer through innovative science, bold ambition, and strong partnerships across the healthcare ecosystem. We focus our science where it can matter most — advancing care in cancers with high unmet need, grounded in a deep understanding of disease biology and deliberate scientific choices that connect discovery to meaningful impact in the real world.

The Medical Director, Oncology Clinical Development - GU (Genitourinary) is the physician within the clinical program team, bringing medical expertise, clinical judgement, and a patient-centered perspective to the design, conduct, and interpretation of clinical studies. This role is accountable for medical monitoring and safety oversight, ensuring that patient safety and clinical integrity are maintained throughout study execution.

Operating within the clinical strategy defined by the Clinical Development Lead (CDL), the Medical Director partners closely with the Senior Scientist and cross-functional teams to ensure that the physician perspective is fully integrated into study delivery. The role serves as a core member of the Clinical Matrix Team (CMT), contributing to study-level decisions, investigator engagement, and regulatory interactions.

For more complex or multi-study programs, the Medical Director may provide medical guidance to other physicians within the program and contribute to broader clinical discussions that inform program-level decisions led by the CDL.

In This Role You Will:

• Serve as the physician within the clinical program team, providing medical expertise across study design, conduct, safety oversight, and data interpretation

• Lead medical monitoring activities for clinical studies, ensuring patient safety, clinical integrity, and compliance with the protocol and regulatory requirements

• Interpret clinical and safety data from a physician perspective, generating insights that inform study-level and program-level decisions led by the CDL

• Partner with the Senior Scientist and cross-functional teams to ensure medical considerations are integrated into study execution and delivery

• Contribute medical expertise to protocol development, ensuring clinical relevance, patient safety, and feasibility within the framework defined by the CDL

• Serve as a core member of the Clinical Matrix Team (CMT), providing the medical voice in study-level discussions and cross-functional decision-making

• Engage with investigators and Key External Experts (KEEs) to support study conduct, scientific exchange, and external representation of the program

• Contribute to regulatory documents, Health Authority interactions, and scientific communications from a physician perspective

Detailed Responsibilities:

Medical Monitoring and Safety Oversight

• Lead medical monitoring activities for assigned clinical studies, including real-time clinical decision-making on patient eligibility, protocol-related medical queries, and safety oversight

• Conduct and oversee medical review of clinical trial data, both directly and through oversight of delegated medical review activities

• Interpret and contextualize safety data in collaboration with pharmacovigilance, ensuring appropriate signal detection, escalation, and benefit–risk assessment at the study level

• Participate in safety review forums, including Safety Review Team (SRT) discussions, Independent Data Monitoring Committee (IDMC) data reviews, and internal governance as required

• Ensure medical monitoring activities are conducted in compliance with GCP, ICH guidelines, and applicable regulatory frameworks

Study Design and Execution

• Provide medical input into protocol development, ensuring clinical relevance, patient safety, and operational feasibility within the clinical strategy defined by the CDL

• Apply clinical judgement to support protocol implementation, addressing medical questions that arise during study conduct and ensuring consistency with the study’s scientific objectives

• Partner with the Senior Scientist to ensure that medical considerations are fully integrated into study execution, data generation, and operational delivery

• Contribute to the development and review of key study documents, including the Informed Consent Form (ICF), protocol deviation management plan (PDMP), and study reference manual (SRM)

• Provide medical input into clinical data generation activities, ensuring alignment with study objectives, patient safety considerations, and the Clinical Development Plan (CDP)

Data Interpretation and Scientific Contribution

• Interpret clinical data from a physician perspective, translating findings into insights on safety, efficacy, and patient impact that inform decision-making by the CDL

• Contribute to study-level and program-level data interpretation, supporting the CDL’s assessment of benefit–risk and clinical positioning

• Contribute to the development of scientific communications, including study reports, clinical study summaries, publications, and congress materials

• Collaborate with investigators on the evaluation and development of abstracts, posters, and manuscripts derived from clinical program data

• Maintain current knowledge of the asset’s biological mechanism, disease landscape, evolving treatment paradigms, and competitive environment to inform clinical interpretation

Regulatory and External Engagement

• Contribute medical expertise to regulatory documents and Health Authority interactions, including responses to clinical and safety queries

• Support preparation of materials for regulatory submissions, advisory boards, and external engagements, providing the physician perspective on clinical data and safety

• Engage with Key External Experts (KEEs), investigators, and scientific collaborators to support study conduct, scientific exchange, and relationship development

• Represent the medical perspective at cross-departmental interactions, including Integrated Evidence Team (IET) and Medical Affairs strategy discussions, as delegated by the CDL

• Contribute to the clinical and technical diligence assessment of business development opportunities as requested

Cross-Functional Collaboration and Clinical Matrix Team

• Serve as a core member of the Clinical Matrix Team (CMT), providing medical leadership within study execution

• Contribute medical expertise to disease area strategy, integrated evidence planning, and Medical Affairs discussions as appropriate

• Collaborate across functions — including Clinical Operations, Biostatistics, Regulatory, and Pharmacovigilance — to ensure alignment on study objectives, patient safety, and data quality

• Contribute to Oncology Clinical Development-wide initiatives and workstreams

Why You?

Working model

This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.

Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• MD (or equivalent medical degree) with board certification or eligibility in oncology, haematology, or a related specialty

• Clinical experience in oncology and/or relevant therapeutic areas, with direct exposure to clinical research or drug development

• Demonstrated experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation

• Strong working knowledge of clinical development processes, including GCP, ICH guidelines, and global regulatory frameworks

• Ability to apply clinical judgement to support study design, patient safety, and real-time medical decision-making within a structured clinical development framework

• Experience operating effectively within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment

• Strong scientific communication skills, with the ability to translate clinical data into clear insights for internal and external audiences

Preferred Qualifications
If you have the following characteristics, it would be a plus:

• Experience in pharmaceutical or biotechnology clinical development across Phase I–III oncology GU studies

• Prior experience contributing to regulatory interactions (e.g., IND submissions, scientific advice, NDA/MAA filings)

• Demonstrated experience engaging with Key External Experts (KEEs), investigators, and scientific collaborators in oncology

• Track record of contributing to clinical publications, congress presentations, or scientific communications

• Deep understanding of oncology disease biology, evolving treatment paradigms, and the competitive landscape across solid tumours and/or haematological malignancies

• Experience in medical monitoring across multiple studies or programmes within a clinical development organisation

• Familiarity with emerging data and analytics approaches (e.g., real-world evidence, AI-enabled insights) to support clinical interpretation and decision-making

What we value
We act with transparency, respect and integrity. We welcome different perspectives and champion inclusion. Bring curiosity, humility and a clear focus on patients.

Fähigkeiten

Warum GSK?

Wir vereinen Wissenschaft, Technologie und Talent, um Krankheiten gemeinsam voraus zu sein.

GSK ist ein globales Biopharma-Unternehmen mit der Ambition, Wissenschaft, Technologie und Talent zu vereinen, um Krankheiten gemeinsam voraus zu sein. Wir haben uns zum Ziel gesetzt, bis zum Ende des Jahrzehnts die Gesundheit von 2,5 Milliarden Menschen positiv zu beeinflussen, als ein erfolgreiches, wachsendes Unternehmen, in dem sich unsere Mitarbeitenden entfalten können. Wir behandeln und schützen vor Krankheiten mit Innovationen im Bereich Spezialmedizin und Impfstoffen. Wir konzentrieren uns auf vier therapeutische Bereiche: Atemwegserkrankungen, Immunologie und Entzündungen; Onkologie; HIV; und Infektionskrankheiten – um die Gesundheit maßgeblich zu beeinflussen.

Menschen und Patient*innen auf der ganzen Welt zählen auf die Medikamente und Impfstoffe, die wir herstellen, daher sind wir bestrebt, ein Umfeld zu schaffen, in dem unsere Mitarbeitenden sich entfalten und sich auf das Wesentliche konzentrieren können. Unsere Kultur, ambitioniert für Patient*innen zu sein, Verantwortung für Wirkungen zu übernehmen und das Richtige zu tun, ist die Grundlage dafür, wie wir gemeinsam für Patient*innen, Aktionär*innen und unsere Mitarbeitenden handeln.

GSK ist ein Arbeitgeber, der sich für Gleichberechtigung und gegen Diskriminierung am Arbeitsplatz einsetzt. Alle qualifizierten Bewerber erhalten dieselbe Bezahlung für gleiche Tätigkeit, und zwar unabhängig von Herkunft, Hautfarbe, Nationalität, Religion, Geschlecht, Schwangerschaft, Familienstand, sexueller Orientierung, Geschlechtsidentität/-präsentation, Alter, Behinderung, genetischen Informationen, Militärdienst sowie vom Status eines geschützten Veteranen oder von einem anderen staatlichen Schutzstatus. Sollten Sie Anpassungen an unserem Prozess benötigen, um Ihnen zu helfen, Ihre Stärken und Fähigkeiten zu demonstrieren, kontaktieren Sie uns unter E-Mail schreiben, wo Sie auch einen Anruf anfordern können.                                                                                                                                                                                                             

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