Study Delivery Lead, Associate Director

GlaxoSmithKline • Collegeville, PA

451d • Hybrid

About The Position

The Associate Director of Study Delivery Lead at GSK is responsible for overseeing the end-to-end design, execution, and reporting of global oncology clinical trials. This role involves strategic planning and leadership within project teams, ensuring studies are delivered on time, within budget, and meet quality standards. The position requires strong stakeholder management skills and the ability to drive operational excellence in a matrix environment, contributing to the growth of GSK's oncology organization.

Requirements

• Bachelor's degree in life sciences or related discipline.
• Extensive clinical development experience equivalent to 6 years as a global study leader in the pharmaceutical industry or CRO environment.
• Proven operational experience leading global oncology clinical trials and knowledge of global regulatory guidelines and ICH/GCP.
• Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
• Proven leadership skills, influencing and negotiation skills.
• Demonstrated experience leading in a matrix environment to deliver projects and manage change.

Nice To Haves

• Oncology phase III global registrational study leadership experience.
• Experience of innovative trial design and decentralized trials initiatives.
• Highly developed communication skills appropriate to the target audience.
• Proven expertise in proactive identification of issues impacting clinical programs.
• Creative thinker able to modernize approach to clinical delivery.

Responsibilities

• Accountable for the global study delivery strategy including country selection and patient engagement strategy.
• Drive assessment, selection, engagement, management, and oversight of appropriate vendors.
• Ensure compliance with ICH/GCP guidelines and GSK SOPs for all products and services delivered for designated studies.
• Make decisions balancing risk/benefit with a clear understanding of impact on the study and project.
• Develop and manage study level budget within project allocation in collaboration with matrix partners.
• Prepare materials for governance and financial review cycles, providing expert clinical operational input into protocol development.
• Lead and conduct investigator meetings and participate in governance meetings as necessary.
• Identify and communicate resource gaps for assigned studies.
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
• Contribute to ways of working and process improvement initiatives.

Benefits

• Competitive salary
• Annual bonus based on company performance
• Healthcare and wellbeing programmes
• Pension plan membership
• Shares and savings programme
• Hybrid working model through Performance with Choice programme

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees