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GSK

Develops medicines, vaccines, and consumer health

Director – US Portfolio Delivery - Cross-TA

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A university degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields), or equivalent demonstrable professional experience in the area.
  • At least 10 years of experience in clinical operations delivery within the pharmaceutical or biotech industry, including leadership of complex, multi-site clinical studies in the US.
  • At least 5 years of experience leading and developing clinical operations leaders or managers, such as Local Delivery Leads, study managers, or Clinical Trial Managers, in a high-volume, high-complexity environment.
  • Demonstrated accountability for study delivery to timelines, quality standards, and regulatory requirements, including risk identification, issue escalation, and problem resolution.
  • Strong working knowledge of ICH Good Clinical Practice, GSK written standards, and US regulatory expectations.
  • Willingness and availability to travel as required.

Responsibilities

  • Lead a team of Local Delivery Leads in a highly complex environment, providing training, coaching, mentoring, line management, and performance management.
  • Manage Local Delivery Lead capacity utilization, aligning capabilities with study requirements, resource availability, and business priorities.
  • Contribute to management of clinical research within the local operating company through participation in relevant leadership teams, supporting consistency, resource utilization, and best practices.
  • Ensure completion of study deliverables within the assigned portfolio to agreed timelines, budget, and quality standards; work with Local Delivery Leads to identify, resolve, or escalate risks and issues that may affect delivery.
  • Identify and share best practices, standardize practices across the US, and represent local and regional clinical operations on global and cross-functional initiatives.
  • Recruit and develop Local Delivery Leads; evaluate internal staff capabilities and competencies and coordinate personal development plans for direct reports.
  • Partner with local and central teams to ensure robust study feasibility considering study complexity, clinical facilities, and monitoring resources.
  • Establish and manage strategic relationships with external vendors to ensure clinical studies are appropriately resourced and executed.
  • Ensure accurate forecasting and achievement of critical study timelines, recruitment targets, patient recruitment cycle times, data and audit quality, and site-related milestones; provide troubleshooting and problem-resolution support to Local Delivery Leads.
  • Assist with audits and inspections of local clinical operations departments, studies, and sites in the country as required.
  • Continuously develop knowledge of Good Clinical Practice, internal company guidelines, standard operating procedures, and new monitoring technologies and capabilities.
  • Lead or participate in regional and global clinical operations projects as appropriate.

Desired Qualifications

  • Experience leading delivery across late-phase and/or registrational cardiovascular, vaccine, and/or steatotic liver disease studies.
  • Experience leading delivery of a portfolio of studies across multiple asset teams.
  • Experience delivering clinical trials in the US, including studies with large site networks, complex protocols, and competitive enrollment environments.

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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