# Medical Director, Oncology Clinical Development - GU **Company**: GSK **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Switzerland---Zug/Medical-Director--Oncology-Clinical-Development---GU_444829-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_7617f6fe-999 ## Description The Medical Director, Oncology Clinical Development - GU (Genitourinary) 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. 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 **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 ## Skills ### Required - oncology - haematology - clinical trials - medical monitoring - safety oversight - data interpretation - regulatory affairs - scientific communication ### Nice to have - experience in pharmaceutical or biotechnology clinical development - prior experience contributing to regulatory interactions - demonstrated experience engaging with Key External Experts (KEEs) - track record of contributing to clinical publications - deep understanding of oncology disease biology --- Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Switzerland---Zug/Medical-Director--Oncology-Clinical-Development---GU_444829-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)