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About the Role
The Medical Director, Oncology Clinical Development - GU is responsible for providing medical expertise, clinical judgment, and a patient-centered perspective to the design, conduct, and interpretation of clinical studies. This role ensures patient safety and clinical integrity through medical monitoring and safety oversight, operating within the clinical strategy defined by the Clinical Development Lead.
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
- 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
- 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
Requirements
- 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
- 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
Skills
- Analytical Thinking
- Clinical Data Interpretation
- Clinical Data Review
- Clinical Development
- Clinical Trial Designs
- Clinical Trials Monitoring
- Digital Fluency
- Drug Regulatory Affairs
- Executive Presence
- Hematology and Oncology
- Learning Agility
- Matrix Leadership
- Real World Evidence (RWE)
- Scientific Presentations
Location
- Stevenage, UK
- Cambridge, UK
Work Type
- Hybrid
Experience Level
- 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
- Experience operating effectively within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment
- Experience in pharmaceutical or biotechnology clinical development across Phase I–III oncology GU studies
- Prior experience contributing to regulatory interactions
- 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
- Experience in medical monitoring across multiple studies or programmes
- Familiarity with emerging data and analytics approaches
Education Level
- MD (or equivalent medical degree) with board certification or eligibility in oncology, haematology, or a related specialty
Salary/Compensations
- $189,750 to $316,250 (US)
- PLN 472,500 to PLN 787,500 (Poland)
Benefits
- Annual bonus
- Eligibility to participate in share-based long-term incentive program
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
About the Company
- GSK has bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.
- GSK's R&D focuses on discovering and delivering vaccines and medicines, combining understanding of the immune system with cutting-edge technology.
- GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing.
- GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
- GSK aims to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
- GSK gets ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
- GSK focuses on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases.
- GSK is committed to creating an environment where its people can thrive and focus on what matters most.
- GSK's culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how they deliver for patients, shareholders and their people.
Equal Opportunity
- GSK is an Equal Opportunity Employer.
- All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.