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GSK

Develops medicines, vaccines, and consumer health

Associate Director – Local Delivery Lead/Local Trial Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRemote in USA

About the Job

Requirements

  • A bachelor’s degree is required.
  • At least 7 years of experience as a clinical trial manager or local delivery lead managing studies, including at least 4 years managing medicines trials.
  • Experience in Phase I–III medicines trials in oncology, specifically lung cancer, including NSCLC and/or SCLC.
  • Solid operational knowledge of clinical research across the study lifecycle, including start-up, recruitment, and closeout, and understanding of the research and development and drug development processes.
  • Experience leading and managing multiple complex study designs, such as umbrella, basket, and platform master protocols.

Responsibilities

  • Provide 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.
  • Lead delivery of a portfolio of oncology studies, applying US lung oncology experience including NSCLC and/or SCLC.
  • Leverage artificial intelligence and digital tools to solve complex problems, streamline processes, improve decision-making, and enhance efficiency for individual work and broader team operations.
  • Deliver studies to recruitment and patient representation targets, timelines, budget, and quality expectations defined in the clinical development plan and study protocol, and comply with local regulations.
  • Acquire and maintain knowledge of disease areas, aligned protocols, disease pathology, the competitive landscape in the US, local treatment guidelines, and local healthcare system requirements.
  • Partner with local medical, global portfolio, and regulatory affairs teams to align medical and scientific requirements with IND, Good Clinical Practice, and International Council for Harmonisation guidelines and support delivery of the regulatory portfolio strategy.
  • Identify, resolve, or escalate risks and issues that may affect the portfolio or disease area, providing troubleshooting and problem-resolution support for efficient portfolio execution.
  • Manage multiple priorities and responsibilities of increased scope and complexity.
  • Recognize and respond to changes affecting a study or program, and assess the suitability of protocols and plans for the local environment.
  • Provide timely feedback to team members to support performance and development needs.
  • Interact effectively with internal senior leadership and external clinical site staff, using stakeholder management and influencing skills.
  • Make quality decisions, resolve problems, set and manage priorities, and manage resource and performance targets for local study deliverables.
  • Assist with audits and inspections of local clinical operations and studies or sites in the US, as required.
  • Represent local or regional clinical operations on global and cross-functional initiatives and serve as a subject matter expert locally or globally when appropriate.

Desired Qualifications

  • A Master of Science, PhD, or equivalent, coupled with previous project management experience.
  • Problem-solving, negotiation, and conflict-resolution skills in a matrix environment.
  • Planning and organizational skills to work efficiently and effectively in a dynamic environment.
  • Knowledge of human research regulations in the US, IND, Good Clinical Practice, International Council for Harmonisation guidelines, and GSK standard operating procedures, policies, and guidelines.
  • Ability to adapt quickly and efficiently to new and changing processes and systems, internally and externally.
  • Availability and willingness to travel as required by the job.
  • Strong written and verbal communication skills.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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