Medical Director, Oncology Clinical Development - Lung & Head/Neck Cancers

GSK; Upper Providence (Delaware County); On-site; USD 119,000 - 198,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Parental leave

Job summary

GlaxoSmithKline seeks an experienced physician to lead medical monitoring within our Clinical Development team. You will oversee safety oversight, protocol design input, and regulatory submissions across oncology studies, collaborating with cross-functional groups to ensure patient safety and scientific integrity.

The role requires MD with oncology/haematology board certification, extensive clinical trial experience, and strong communication skills to translate data into actionable insights for

Qualifications

• MD (or equivalent medical degree) with board certification or eligibility in oncology/haematology or a related specialty.
• Demonstrated experience in clinical trial conduct, including medical monitoring and safety review.
• Experience translating clinical data into clear insights for internal and external audiences.
• Strong knowledge of GCP/ICH guidelines and global regulatory frameworks.
• Experience engaging with KEEs, investigators, and scientific collaborators in oncology.

Responsibilities

• Lead medical monitoring activities for clinical studies, ensuring patient safety and protocol compliance.
• Provide medical input into protocol development and study execution.
• Interpret safety data and provide insights for decision-making at study and programme levels.
• Contribute to regulatory documents and Health Authority interactions from a physician perspective.
• Collaborate across functional teams to ensure alignment on study objectives, safety, and data quality.
• Engage with investigators and external experts to support scientific exchange and representation.

Skills

Analytical Thinking

Clinical Data Interpretation

Clinical Development

Clinical Pharmacology

Regulatory Affairs

Education

MD with oncology/haematology board cert

Job description

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: Our approach to R&D 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.

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

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
• 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

Preferred Qualifications

• Experience in pharmaceutical or biotechnology clinical development across Phase I–III Lung & Head/Neck oncology studies
• Strong working knowledge of clinical development processes, including GCP, ICH guidelines, and global regulatory frameworks
• 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 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.

Why GSK?

Unifying 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. 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 https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.