Medical Director, Oncology Clinical Development Hematology

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 currentlyproposed 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 peoples 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. Were uniting science technology and talent to get ahead of disease together.
Find out more:
Our approach to R&D

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 is the physician within the clinical program team bringing medical expertise clinical judgement and a patient-centered 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.

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 benefitrisk 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 studys 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 CDLs assessment of benefitrisk 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 assets 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. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.

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 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
• Experienceapplying 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
If you have the following characteristics it would be a plus:

• Experience in pharmaceutical or biotechnology clinical development across Phase IIII 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

uses artificial intelligence (AI) tools as part of the recruitment process to assist in screening and assessing applicants. Final hiring decisions are made by hiring managers with support from recruiters.

advertisement relates to a current vacancy.

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 $222750 to $371250. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the 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 Salary Range / Polski przedział wynagrodzenia: PLN 455250 to PLN 758750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidates skills experience education level and the market rate for the addition this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidates skills experience education level and the market rate for the role. Offers are typically made within the advertised range based on the candidates skills experience and qualifications with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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 were 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.

If you require an accommodation or other assistance to apply for a job at GSK please contact the appropriate Recruitment Staff by emailing us at -

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 GSKs 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 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:

Director