About this opportunity
GlaxoSmithKline lists this Medical Director-Oncology Clinical Development - GI opportunity in waltham, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
Overview
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.
Medical Director, Oncology Clinical Development - GI
is the physician within the clinical programme team, bringing medical expertise, clinical judgement, and a patient-centred 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 programmes, the Medical Director may provide medical guidance to other physicians within the programme and contribute to broader clinical discussions that inform programme-level decisions led by the CDL.
In This Role You Will:
Serve as the physician within the clinical programme 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 programme-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 programme
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 contextualise 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 programme-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 programme 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
Working Model
This role is hybrid and based in Switzerland. You will be expected to be on-site regularly and collaborate with colleagues across locations.
Basic Qualifications
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
Experience in pharmaceutical or biotechnology clinical development across Phase I-III GI oncology 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 in you
We act with transparency, respect and integrity. We welcome different perspectives and champion inclusion. Bring curiosity, humility and a clear focus on patients. If you are motivated to drive clinical progress and to grow with a team that values collaboration and impact, we encourage you to apply.
Skills
Analytical Thinking, Clinical Data Interpretation, Clinical Development, Clinical Pharmacology, Clinical Trial Designs, Clinical Trials Monitoring,
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Worksite address
waltham, MA, 02254, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.