Medical Director-Oncology Clinical Development - GI
hace 5 días
London
This job is with GSK, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. 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. At 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 R&D 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. Find out more: _ 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. The 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 Why You? 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 We are seeking professionals with the following required skills and qualifications to help us achieve our goals: • 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 If you have the following characteristics, it would be a plus: • 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. How to apply Please submit your CV and a short cover letter that explains how your experience matches the role and what motivates you to join us. We welcome applicants from all backgrounds and look forward to hearing from you. Skills Analytical Thinking, Clinical Data Interpretation, Clinical Development, Clinical Pharmacology, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations • If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $222,750 to $371,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim 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. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that 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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at _ where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the _ where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at _
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