Clinical Development Manager

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

The Clinical Development Manager (CDM) will be responsible for leading cross-functional teams in delivering quality clinical studies and/or tissue bank studies within the Clinical Unit Cambridge (CUC) with end-to-end involvement and oversight from protocol development, study set up, study execution, study closeout and final study report. The role is based within GSK's Phase 1 Clinical Pharmacology Unit (Clinical Unit Cambridge).

In this role you will:

• Lead the operational delivery and quality of clinical trials and/or tissue bank studies within the CUC, ensuring compliance with ICH/GCP, regulatory, ethical requirements, and GSK written standards.
• Maintain end-to-end oversight of study conduct and communications, including risk and issue management to make decisions which balance benefit/risk with a clear understanding of impact on project; take actions to mitigate risk where appropriate.
• Develop, review and/or enhance the operational and scientific robustness of clinical trial documentation including Study Delivery Plans, Study Protocols and manuals, Informed Consent Forms, clinical study timelines, costing templates, and other study documents as required.
• Coordinate and submit the required package of regulatory documents for approvals to conduct the clinical trial, e.g. Ethics Committee and Regulatory Clinical Trial Applications (CTAs), NHS R&D, and manage subsequent correspondence, approvals and amendments through to close-out of the clinical trial.
• Maintain study documentation for the Investigator Site File for monitoring and inspection-readiness.
• Build and collaborate with other functions both within the CUC and wider GSK. Interact effectively across boundaries with functions using influencing and relationship-building skills.
• Manage and lead on multiple project workstreams, alongside clinical trial management, and deliver to demanding deadlines.

Basic Qualifications & Skills:

• Bachelor of Science or equivalent, or professional qualification in a life science field.
• Experience of successfully leading on end-to-end clinical study delivery as a study manager, clinical development associate, clinical trial coordinator or other similar role within a Phase I Clinical Pharmacology Unit.
• Understanding of the drug development process, with particular expertise in early clinical development, clinical trials regulatory requirements, and clinical trial terminology.
• Experience working within a GCP environment (or similar).
• Demonstrated excellent organisation and leadership skills in a matrix team environment.

Preferred Qualifications & Skills:

• Ability to deliver to demanding deadlines, with an agile and flexible approach, whilst maintaining quality.
• Exemplary written and verbal communication.
• Able to build relationships in a dynamic and matrix environment, including navigating, influencing and communicating complex discussions and issues, encouraging alternative perspectives, managing change, and developing solutions.

Closing Date for Applications – 13th July 2025.

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.