About The Position

The Director of US Oncology Portfolio Delivery, also referred to as the US Local Delivery Lead Director, provides leadership, oversight, and local US delivery of studies supporting global oncology R&D programs. The role is accountable for a portfolio of assets and manages US Program Leads and US Local Delivery Leads to ensure oncology clinical studies meet required quality standards, GSK written standards, and ICH GCP. The Director operates independently in a highly complex, high-volume strategic market. The position leads, coaches, mentors, and manages the performance of a team of Local Delivery Leads; manages resource capacity and contributes to resourcing solutions; and supports consistent, effective clinical research operations across the local organization. The Director is accountable for study project-management deliverables, timelines, budgets, and quality, and works with delivery leads to identify, resolve, or escalate risks and issues. The role also supports study feasibility, strategic vendor relationships, recruitment and site milestones, quality planning, audits and inspections, and regional or global clinical operations initiatives. Travel is required as the job requires.

Requirements

  • University degree in a science field such as Medicine, Pharmacy, Biochemistry, or Biology, or equivalent demonstrable professional experience in the area.
  • At least 10 years of clinical operations delivery experience in 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 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.
  • Available and willing to travel as the job requires.

Nice To Haves

  • 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 GCP, GSK written standards, and US regulatory expectations.
  • Experience leading delivery across late-phase and/or registrational oncology studies.
  • Familiarity with oncology 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.

Responsibilities

  • Lead a team of Local Delivery Leads in a complex, high-volume 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, aligned with capabilities, study requirements, resource availability, and business priorities.
  • Contribute to management of clinical research within the local organization through participation in applicable leadership teams, promoting consistency, resource utilization, and best practices.
  • Ensure completion of project-management deliverables for studies assigned to the local organization within agreed timelines, budgets, and quality standards.
  • Work with Local Delivery Leads to identify and resolve or escalate risks and issues that could affect study delivery.
  • Identify and share best practices, standardize processes across the local organization or region, and represent local or regional clinical operations in global and cross-functional initiatives.
  • Recruit and develop Local Delivery Leads; evaluate internal staff capabilities and competencies and coordinate 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 studies are adequately resourced and executed.
  • Ensure study timelines are accurately forecast and achieved, and that recruitment targets, patient recruitment cycle times, data and audit quality, and site milestones are met.
  • Provide troubleshooting and problem-resolution support to Local Delivery Leads to enable productive and efficient study delivery.
  • Work with the Clinical Operation Director and Local/Regional Quality, Capability & Risk Manager to identify management-monitoring process checks for inclusion in the local quality plan.
  • Assist with audits and inspections of local clinical operations and studies or sites in the country, as required.
  • Maintain knowledge of GCP, company guidelines, SOPs, monitoring technologies, and capabilities; serve as an expert in ICH GCP and GSK written standards for Local Delivery Leads.
  • Lead or participate in regional or global clinical operations projects, as appropriate.
  • Travel as required by the job.

Benefits

  • Annual bonus.
  • Eligibility to participate in a share-based long-term incentive program, dependent on role level.
  • Health care and other insurance benefits for employees and family.
  • Retirement benefits.
  • Paid holidays.
  • Vacation.
  • Paid caregiver, parental, and medical leave.
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