The posting
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.
Business Introduction 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
Position Summary 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.
GSK Oncology Clinical Development is seeking a highly skilled and motivated Executive Medical Director, Oncology Early Clinical Development Lead (ECDL) to join our dynamic Oncology Research and Development team. In this role the successful candidate will create a strong link between Clinical Development and Pre-clinical/ Discovery teams to improve forward and reverse translation and, thereby, increase the success of our Oncology clinical portfolio. They will be responsible for leading a team of talented Oncology Early Clinical Development Medical Directors and Clinical Scientists who will design and execute early-phase clinical studies, as well as contribute to the translational research strategy for early phase clinical assets. This role offers a unique opportunity to bridge the gap between preclinical research and clinical development, ensuring the successful translation of innovative therapies from the lab to the clinic.
Key Responsibilities
Clinical Study Design & Execution:
- Accountable for the clinical development plans (CDPs) for a portfolio of early phase (Phase I/II) clinical study protocols, including first-in-human (FIH) trials, dose-escalation/expansion studies, and proof-of-concept (POC) studies.
- Accountable for overall benefit:risk of a clinical program.
- Accountable for driving the end-to-end clinical development strategy and alignment to target medicine profiles (TMP) and integrated evidence plans (IEP), spanning all phases of development, including trial design, execution, and interpretation and delivery of trial results
- Leads clinical development discussions and teams at regulatory interactions and accountable for drafting clinical components of regulatory submissions/files (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses.
- Participate as a core member of the Early Development Team (EDT) and provide a single Clinical Development accountability at the program level within these teams and other cross-functional partnerships, e.g., with Medical Affairs, Integrated Evidence, Publications, and Global and Regional Commercial functions
- Ensure that all clinical studies are conducted in compliance with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and GSK policies and procedures.
- Lead the cross-functional Early Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise, and customer insight for the program
Translational Research Strategy:
- Oversee the development and execution of the clinical development components of the overall translational science strategy in partnership with Oncology Early Development Leaders, Oncology Translational Science, pre-clinical Oncology Research teams (ETCT & ITCT), AI/ML, Clinical Pharmacology & Experimental Medicine, Research Technologies
- Partner with the Oncology Tumor Teams (OTTs) to develop the translational strategy across assets within a given tumor and support OTT activities with a clinical and translational focus
- Drive advancements in translational research and emerging technologies to improve study designs and foster innovation
Data Analysis and Interpretation:
- Interpret complex translational and clinical data and identify trends for clinical and regulatory documents consult on safety analyses, and responses to health authority queries
- Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data, interpretation, and content.
- Prepare for and lead governance discussions in close collaboration with cross-functional Early Development or Medicine Development Team and other business lines
- Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, annual reports, etc.)
- Lead and provide clinical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
- Present study results and translational insights to internal and external stakeholders, including senior management, scientific advisory boards, and regulatory agencies.
Collaboration and Communication
- As a therapy area subject matter expert, accountable for integrating inputs from across disciplines (research, clinical, medical, scientific, statistical, commercial, regulatory, manufacturing, operations, etc.) to ensure alignment and successful execution of translational research initiatives.
- Build and maintain strong relationships with key external experts (KEEs), academic collaborators, and external research organizations, including the Oncology Translational Network
- Collaborate with Principal Investigators and Steering Committees in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
- Serve as program medical experts for internal and external collaborators, investigators, and consultants
Oncology Clinical Development Leadership
- Lead, coach and mentor a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists. Provide direct reports with ongoing coaching, development and leadership; includes holding regular staff meetings, check-ins and 1:1 meetings
- Guide direct reports to ensure cross-functional integration, coordination, collaboration, and alignment to enable effective and efficient CDP and translational strategy execution
- Foster the development of our culture within the team of direct reports: be bold, be swift, act with integrity, as a OneOncology community
- Contribute to the establishment of standards for clinical documents and data review processes across Oncology Clinical Development.
Why You?
Work Arrangement 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:
- MD or equivalent medical degree required
- Clinical and research experience in lung cancer
- Documented experience as a physician scientist in the pharmaceutical industry or an academic oncology setting, with experience in oncology early phase clinical trials and translational research.
- Experience interpreting pre-clinical data packages and providing clinical recommendations on indication and patient selection
- Experience designing and executing early phase clinical studies, including FTIH and POC trials
- Experience in lung cancer treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions
- Experience developing and driving translational strategy: biomarker, companion diagnostic, PK/ PD modeling and simulation
- Experience managing direct reports and leading matrix teams
- Global regulatory experience
Preferred Qualifications
- MD or equivalent medical degree with PhD preferably in biological sciences or quantitative/computer science with documented application towards biomedical
Skills
Clinical Data Interpretation, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations, Strategic Direction
• 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 $284,250 to $473,750. 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.
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 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.
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