Senior Medical Director, Oncology Clinical Development - GU

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 For candidates seeking to be located at our Stevenage site, this role will temporarily be based ever, 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.

The Senior Medical Director, Oncology Clinical Development - GU will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Sr. Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant internal scientific and medical leaders in order to lead clinical data generation activities.

You will also have a leading role in managing effective relationships with Key External Experts. This role requires an experienced professional capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.
PLEASE NOTE
:
This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK’s Switzerland (Zug), Poland (Warsaw), UK (Stevenage or London HQ) or US (PA or MA) sites.

• Exhibit leadership at the program and cross-functional level and collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
• Oversee the development of high-quality protocols aligned with the Clinical Development Plan to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
• Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and medical data review.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participa…