Director, Clinical Science – Oncology Clinical Development

GlaxoSmithKline LLC; Philadelphia (Philadelphia County); Vor Ort; USD 160.000 - 240.000; Vollzeit

Zusammenfassung

GlaxoSmithKline LLC in Stevenage (with planned relocation to Cambridge, UK) seeks a Director, Clinical Science – Oncology Clinical Development to provide scientific leadership across study design, data interpretation, and regulatory deliverables within an asset-level framework.

You will partner with cross-functional teams, contribute to regulatory submissions, engage external experts, and uphold rigorous scientific standards to advance oncology programmes from concept through completion.

Aufgaben

• Provide scientific leadership across study design, data review, and interpretation within the asset-level clinical strategy.
• Serve as a core member of the Clinical Matrix Team (CMT), ensuring alignment of study objectives and timelines.
• Provide scientific insight to inform asset-level strategy, benefit-risk assessment, and programme decisions.
• Ensure scientific accuracy and quality of key clinical/regulatory documents (protocols, IBs, CSRs, submissions).
• Analyse and interpret data to inform safety, efficacy, and patient populations.
• Engage with investigators and external experts to support study execution and scientific exchange.
• Contribute to a culture of scientific excellence and continuous improvement within Oncology Clinical Development.

Jobbeschreibung

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 toCambridge, 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.

The Director, Clinical Science – Oncology Clinical Development provides scientific leadership across defined components of study design, conduct, data review, and interpretation within an assigned clinical programme. Reporting to the Clinical Development Lead (CDL), this role operates within the asset-level clinical strategy and contributes scientific depth and rigour to the execution of the Clinical Development Plan (CDP).

The Director, Clinical Scientist partners closely with the Senior Scientist and cross-functional teams to support delivery of clinical studies, ensuring scientific quality, data integrity, and robust interpretation of clinical data. This role contributes to both study-level activities and broader programme insights, without holding accountability for asset-level strategy or overall study delivery.

This is a scientific individual contributor role requiring deep oncology clinical development expertise, strong analytical and collaboration skills, and the ability to operate effectively within a complex, matrixed environment.

In This Role You Will:

1. Provide scientific leadership across defined components of study-level activities, including protocol development, study design, data review, and interpretation, within the strategic direction set by the CDL
2. Serve as a core member of the Clinical Matrix Team (CMT), ensuring scientific alignment across study objectives, timelines, and deliverables
3. Provide scientific insight to the CDL and Senior Scientist to inform asset-level strategy, benefit-risk assessment, and programme-level decision-making
4. Ensure the scientific quality and consistency of key clinical and regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, and submission materials
5. Apply scientific and clinical expertise to analyse and interpret data, ensuring rigour, integrity, and relevance to the target patient population
6. Engage with internal and external stakeholders, including investigators and Key External Experts, to support study execution and scientific exchange
7. Contribute to a culture of scientific excellence, innovation, and continuous improvement within Oncology Clinical Development

Detailed Responsibilities:

Study Design and Execution

1. Provide scientific input into protocol development and study design, ensuring robustness, feasibility, and alignment with CDP-defined objectives and regulato y requirements
2. Author or co-author key study documents (e.g., Clinical Study Proposals), contributing to preparation and presentation at governance forums such as Protocol Review Boards
3. Support study conduct by addressing scientific questions, ensuring data integrity, and maintaining alignment with protocol and regulatory standards
4. Provide scientific input into study-level decisions related to protocol implementation and study conduct, within the strategic framework defined by the CDL
5. Present and support the scientific rationale and study design at Investigator Meetings and respond to scientific inquiries from study sites
6. Support implementation of study-level Go/No-Go criteria aligned to the asset-level decision framework defined by the CDL

Data Generation, Analysis, and Interpretation

1. Analyse and interpret clinical data to generate insights on safety, efficacy, and patient populations
2. Integrate data from internal and external sources (e.g., literature, competitor data, emerging science) to inform study and programme understanding
3. Provide scientific input into data review and interpretation activities, in collaboration with Medical Directors and pharmacovigilance
4. Translate study findings into clear scientific insights to inform programme progression and support CDL-led decision-making

Clinical and Regulatory Deliverables

1. Contribute to development of clinical and regulatory documents, including protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and submission materials
2. Ensure scientific accuracy, consistency, and quality across study documentation
3. Support preparation of regulatory submissions and responses to Health Authority queries
4. Contribute to regulatory reporting requirements (e.g., DSURs, INDSRs) and ensure alignment with regulatory standards

Cross-Functional Collaboration & Scientific Contribution

1. Serve as a core member of the CMT, partnering with Clinical Operations, Statistics, Safety, Regulatory, and Medical Affairs to support integrated study delivery
2. Provide scientific expertise to cross-functional discussions, including integrated evidence planning and disease-area forums, as appropriate
3. Participate in internal and external scientific interactions with investigators, Key External Experts, advisory boards, and collaborators
4. Contribute to scientific communications, including publications, congress presentations, and study-related materials

Ways of Working & Continuous Improvement

Identify scientific and operational risks at the study level and provide input into mitigation strategies

Support and drive implementation of consistent ways of working and process improvements across the programme

Participate in Oncology Clinical Development initiatives and workstreams to strengthen standards, processes, and capabilities

Engage in ong