Job Description

Site Name: 

• Cambridge MA

• - GSK HQ, UK - Hertfordshire - Stevenage

• - Upper Providence

Posted Date: 

• Oct 29, 2024

Role Overview:

This role within Global Clinical Oncology R&D will serve as a clinical sciences leader on global oncology studies and contribute to program-level activities. The individual will be responsible for the delivery of quality study strategy and design, understanding the analysis and interpretation of data throughout the study, including leading clinical data review ongoing throughout study conduct. Additionally, the role involves the end-to-end writing of protocols (from protocol concept to final study report) and contributing to the development of informed consent forms and other study-related documents.

Key Responsibilities:

• Clinical Development Oncology:

•   - Review and/or enhance the technical and scientific robustness of project-level clinical development plans.

•   - Support regulatory interactions, including contributing to briefing documents, presentations, addressing questions, and responses.

•   - Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for all products and services delivered for their designated studies.

•   - Contribute to the development of end-to-end clinical development strategy.

•   - Make decisions that balance risk/benefit with a clear understanding of the impact on the study and project; take action to mitigate risk where appropriate.

•   - Actively partner to build relationships and collaborate with oncology-aligned staff in other global functions.

•   - Cultivate strong relationships and robust communication among the clinical study/project team and GSK’s Oncology Clinical Development Organization. This includes training, education, onboarding, and problem-solving in the conduct of clinical trials.

•   - Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.

• Study Design and Interpretation:

•   - Design and interpret study results that provide data to adequately address questions concerning efficacy/effectiveness, safety, applicability to the targeted patient population, and clinical and commercial value. Ensure that patient safety is of paramount concern and that regulatory requirements are incorporated.

•   - Provide leadership at the study level to assure the overall safety of the study subjects.

•   - Drive/contribute to clinical components of the Investigator’s Brochure (IB) and documents for regulatory submissions and advisory requirements, including scientific advice, IND, EoP2, preNDA/BLA meetings, NDA/BLA, and MAA documents.

•   - Serve as a product, protocol, and project subject matter expert to support internal and external customers.

•   - Work with external experts to develop abstracts, manuscripts, and study design presentations.

Qualifications:

• Experience in clinical development, particularly in oncology.

• - Strong understanding of ICH/GCP guidelines and regulatory requirements.

• - Proven ability to lead and collaborate with cross-functional teams.

• - Excellent communication and problem-solving skills.

• - Ability to make informed decisions balancing risk and benefit.

This role is critical in ensuring the successful design, execution, and interpretation of global oncology studies, contributing to the advancement of clinical development strategies and regulatory compliance.