Medical Director, Oncology Clinical Development

GSK•Waltham, PA

2d•Hybrid

About The Position

The 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. 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.

Requirements

MD (or equivalent medical degree) with board certification or eligibility in oncology, hematology, or hematology oncology with experience in treating patients with clonal myeloid disorders.
Clinical experience in oncology and/or relevant therapeutic areas, with direct exposure to clinical research or drug development
Experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation
Experience leading or supporting clinical development activities in accordance with GCP and ICH guidelines and global regulatory frameworks
Experience applying 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
Experience translating clinical data into clear insights for internal and external audiences

Nice To Haves

Experience in pharmaceutical or biotechnology clinical development across Phase I–III 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 tumors and/or hematological malignancies
Experience in medical monitoring across multiple studies or programs within a clinical development organization
Familiarity with emerging data and analytics approaches (e.g., real-world evidence, AI-enabled insights) to support clinical interpretation and decision-making

Responsibilities

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
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
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)
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
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
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