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GSK

Develops medicines, vaccines, and consumer health

Director of US Oncology Portfolio Delivery

Clinical Research OperationsPosted on Nov 10
Full-timePhiladelphia, PA, USA

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 (e.g., LDLs, study managers, CTMs) in a high-volume, high-complexity environment.
  • At least 5 years of experience delivering oncology clinical trials in the US, including studies with large site networks, complex protocols, and competitive enrollment environments.
  • At least 3 years of experience leading delivery of a portfolio of oncology studies across multiple asset teams.

Responsibilities

  • Lead a team of Local Delivery Leads in a highly complex environment, providing training, coaching, mentoring, line management, and performance management.
  • Manage capacity utilization of Local Delivery Lead resources and contribute to resourcing solutions, including multi-country support, aligning capabilities with study requirements, resource availability, and business priorities.
  • Contribute to overall clinical research management within the Local Operating Company through applicable leadership teams to support consistency, resource utilization, and best practice.
  • Ensure completion of project management deliverables for all assigned studies to agreed timelines, budget, and quality standards; work with Local Delivery Leads to identify and resolve or escalate risks and issues that may affect study delivery.
  • Identify and share best practices, standardize processes across the Local Operating Company or region, and represent local or regional clinical operations in global and cross-functional initiatives.
  • Recruits and develops Local Delivery Leads; evaluates internal staff capabilities and competencies and coordinates implementation of 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 study timelines are accurately forecasted and achieved, and recruitment targets, patient recruitment cycle times, data and audit quality, and site-related milestones are met.
  • Provide troubleshooting and problem-resolution support for Local Delivery Leads to enable productive, efficient study delivery.
  • In collaboration with the Clinical Operation Director and Local/Regional Quality, Capability & Risk Manager, identify management monitoring process checks linked with Local Delivery Lead activities for inclusion in the local quality plan to ensure quality and integrity of clinical studies conducted in the Local Operating Company.
  • Assist with audits and inspections of the local clinical operations department and studies or sites in the country, as required.
  • Continuously develop knowledge of Good Clinical Practice, internal company guidelines, standard operating procedures, new monitoring technologies, and capabilities; serve as an expert in ICH Good Clinical Practice and GSK written standards for Local Delivery Leads.
  • Lead or participate in regional and global clinical operations projects, as appropriate.
  • Travel as required.

Desired Qualifications

  • 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.
  • Experience leading delivery across late-phase and/or registrational oncology studies.
  • Familiarity with oncology-specific operational challenges, including high protocol complexity and amendment frequency, specialized site types and networks, and competitive enrollment and site capacity constraints.
  • Experience operating across multiple oncology indications or programs within a portfolio.

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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