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GSK

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

Location
(Multi-state)Hybrid
Posted
Posted yesterday (employer shows the date only)
Source
Workday (employer's applicant tracking system)
Category
Clinical/Pharmacist
Industry
Pharma/Biotech
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From the employer's 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

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