[Hiring] Associate Director, Local Delivery Lead/Local Trial Manager @GSK

Role Description

The Associate Director, Local Delivery Lead/Local Trial Manager provides end-to-end leadership for US clinical study delivery, serving as the primary operational link between global study teams and local US operations. It is accountable for achieving recruitment (including patient representation), timelines, budget, quality, and regulatory compliance while leading a highly matrixed, cross-functional team of internal stakeholders, vendors, and investigative sites.

• Provides portfolio-level leadership and accountability for US clinical delivery, aligning clinical operations, cross-functional partners, vendors, and investigative sites to drive consistent execution, performance, and strategic outcomes across the portfolio.
• US lung oncology experience, including NSCLC and/or SCLC, to drive delivery of a portfolio of oncology studies.
• Demonstrates the ability to leverage AI and digital tools to solve complex problems, streamline processes, improve decision-making, and enhance efficiency for both individual work and broader team operations.
• Accountable for delivery of a portfolio of studies to recruitment targets, patient representation targets, time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations.
• Acquires and maintains an appropriate level of knowledge on a disease area(s), aligned protocols, pathology of disease area, competitive landscape within the US, local treatment guidelines and local health care system requirements.
• Partners with local medical, global portfolio, and regulatory affairs teams to align medical and scientific requirements with IND, GCP, and ICH guidelines and support delivery of the regulatory portfolio strategy.
• Proactively identifies, resolves, and/or escalates risks and issues that may impact the portfolio/disease area providing effective troubleshooting and problem-resolution support to ensure efficient and productive portfolio execution.
• Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity.
• Recognizes and reacts to changes that impact a study and/or program and has the skill set to assess the appropriateness of protocol/plans in the local environment.
• Provides timely feedback to team members to support performance and development needs.
• Strong stakeholder management and influencing skills are essential, as the role requires effective interaction with internal senior leadership and external clinical site staff.
• Demonstrates track record in quality decision-making and problem resolution.
• Able to set and manage priorities, resource and performance targets of local study deliverables.
• As required, assists with audits/inspections of local clinical operations department and study/sites in the US.
• Represents local/regional clinical operations on global and cross-functional initiatives. May serve in a subject matter expert (SME) capacity locally/globally.

Qualifications

• Bachelor’s degree
• 7+ years’ experience as a clinical trial manager/local delivery lead managing studies and 4+ of the years managing Medicines trials.
• Phase I-III Medicines trial experience in Oncology, specifically in Lung Cancer, including NSCLC and/or SCLC.
• Experience with solid operational knowledge of clinical research in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug development process.
• Experience with leading and managing multiple complex design studies, such as master protocols of umbrella, basket and platform trial designs, etc.

Requirements

• Master of Science, PhD or equivalent coupled with previous project management experience.
• Effective problem solving, negotiation and conflict resolution skills in a matrix environment.
• Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment.
• Deep knowledge of human research regulations in the US, IND/GCP/ICH-guidelines and GSK SOP/POL/guidelines.
• Works in an environment that is constantly evolving with new processes and systems, internally and externally and adapts to these changes quickly and efficiently.
• Available and willing to travel as job requires.
• Strong written and verbal communications skills are required.

Benefits

• US annual base salary ranges from $129,750 to $216,250.
• Annual bonus and eligibility to participate in share-based long-term incentive program.
• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• Paid holidays and vacation.
• Paid caregiver/parental and medical leave.