Stellenbeschreibungph3Business Introduction /h3pAt 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 RD 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. /ppFind out more: /ppOur approach to RD /ppCancer 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. /ppThe Medical Director, Oncology Clinical Development is the physician within the clinical program 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. /ppOperating 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. /ppFor 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. /ph3In This Role You Will: /h3ulliServe as the physician within the clinical program team, providing medical expertise across study design, conduct, safety oversight, and data interpretation /liliLead medical monitoring activities for clinical studies, ensuring patient safety, clinical integrity, and compliance with the protocol and regulatory requirements /liliInterpret clinical and safety data from a physician perspective, generating insights that inform study-level and program-level decisions led by the CDL /liliPartner with the Senior Scientist and cross-functional teams to ensure medical considerations are integrated into study execution and delivery /liliContribute medical expertise to protocol development, ensuring clinical relevance, patient safety, and feasibility within the framework defined by the CDL /liliServe as a core member of the Clinical Matrix Team (CMT), providing the medical voice in study-level discussions and cross-functional decision-making /liliEngage with investigators and Key External Experts (KEEs) to support study conduct, scientific exchange, and external representation of the program /liliContribute to regulatory documents, Health Authority interactions, and scientific communications from a physician perspective /li /ulh3Detailed Responsibilities /h3h3Medical Monitoring and Safety Oversight /h3ulliLead medical monitoring activities for assigned clinical studies, including real-time clinical decision-making on patient eligibility, protocol-related medical queries, and safety oversight /liliConduct and oversee medical review of clinical trial data, both directly and through oversight of delegated medical review activities /liliInterpret and contextualize safety data in collaboration with pharmacovigilance, ensuring appropriate signal detection, escalation, and benefit–risk assessment at the study level /liliParticipate in safety review forums, including Safety Review Team (SRT) discussions, Independent Data Monitoring Committee (IDMC) data reviews, and internal governance as required /liliEnsure medical monitoring activities are conducted in compliance with GCP, ICH guidelines, and applicable regulatory frameworks /li /ulh3Study Design and Execution /h3ulliProvide medical input into protocol development, ensuring clinical relevance, patient safety, and operational feasibility within the clinical strategy defined by the CDL /liliApply clinical judgement to support protocol implementation, addressing medical questions that arise during study conduct and ensuring consistency with the study’s scientific objectives /liliPartner with the Senior Scientist to ensure that medical considerations are fully integrated into study execution, data generation, and operational delivery /liliContribute 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) /liliProvide medical input into clinical data generation activities, ensuring alignment with study objectives, patient safety considerations, and the Clinical Development Plan (CDP) /li /ulh3Data Interpretation and Scientific Contribution /h3ulliInterpret clinical data from a physician perspective, translating findings into insights on safety, efficacy, and patient impact that inform decision-making by the CDL /liliContribute to study-level and program-level data interpretation, supporting the CDL’s assessment of benefit–risk and clinical positioning /liliContribute to the development of scientific communications, including study reports, clinical study summaries, publications, and congress materials /liliCollaborate with investigators on the evaluation and development /li /ul /p #J-18808-Ljbffr
