Director of US Oncology Portfolio Delivery

Job Purpose

The Director of US Oncology Portfolio Delivery (US Local Delivery Lead Director) provides leadership, oversight and local US delivery of studies in support of global oncology R&D programs. The LDL-Director is accountable for a portfolio of assets, and manages the activities of US Program Leads (PLs) and US Local Delivery Leads (LDLs) to ensure the delivery of all oncology clinical studies to the required quality standards, GSK written standards and ICH GCP. The LDL-Director operates independently and effectively in a highly complex, high volume, strategic market.

Key Responsibilities

• Leads a team of LDLs operating in a highly complex environment due to scale and volume of studies conducted, providing training, coaching, mentoring, line and performance management.
• Responsible for effectively managing capacity utilisation of LDL resources and contributes to resourcing solutions including multi-country support by LDLs, ensuring alignment of capabilities with study requirements, resource availability and business priorities.
• Contribute to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilisation of resources and best practice.
• Accountable for ensuring the completion of all project management deliverables for all studies assigned to the LOC to agreed timelines, budget and quality standards.
• Works with the LDLs to identify and resolve or escalate risks and issues that may impact study delivery.
• Responsible for identifying and sharing best practices, standardizing across the LOC / region and representing local/regional clinical operations on global and cross functional initiatives.
• Recruits and develops LDLs; evaluates capabilities and competencies of internal staff, identifies and coordinates implementation of personal development plans for direct reports.
• Partners with local and central teams to ensure robust study feasibility with reference to study complexity, clinical facilities and monitoring resource.
• Establishes and manages key strategic relationships with external vendors to ensure clinical studies are appropriately resourced and executed as necessary.
• Ensures that critical study timelines related to study activities are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met.
• Provides trouble-shooting and problem resolution support for LDLs to ensure productive, efficient study delivery.
• In collaboration with Clinical Operation Director and Local/Regional Quality, Capability & Risk Manager identifies management monitoring process checks linked with LDL activities that require inclusion in the local quality plan.
• Assists with audits/inspections of local clinical operations department & study / sites in the country, as required.
• Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring technologies and capabilities.
• Serves as an expert in ICH GCP and GSK written standards for LDLs.
• Leads or participates in regional/global clinical operations projects (as appropriate).
• Available and willing to travel as job requires.

Basic Qualifications

• 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

Preferred 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-GCP, GSK written standards, and US regulatory expectations
• Experience leading delivery across late phase and/or registrational oncology studies is highly valued
• Familiarity with oncology specific operational challenges, such as high protocol complexity and amendment frequency, specialized site types and networks, competitive enrollment and site capacity constraints
• Experience operating across multiple oncology indications or programs within a portfolio