Director, US Portfolio Delivery (cross-TA)

Job Purpose

The Director of US Portfolio Delivery (US Local Delivery Lead Director) provides leadership, oversight and local US delivery of studies in support of global 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 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

• Lead a team of LDLs operating in a highly complex environment due to scale and number of US studies conducted.
• Provide training, coaching, mentoring, line and performance management.
• Manage capacity utilization of LDL 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.
• Ensure completion of all deliverables for studies within assigned portfolio to agreed timelines, budget and quality standards.
• Identify and resolve or escalate risks and issues that may impact study delivery.
• Identify and share best practices, standardize across the US and represent local/regional clinical operations on global and cross functional initiatives.
• Recruit and develop LDLs; evaluate capabilities and competencies of internal staff and coordinate personal development plans.
• Partner with local and central teams to ensure robust study feasibility.
• Establish and manage key strategic relationships with external vendors.
• Ensure critical 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 trouble-shooting and problem resolution support for LDLs.
• Assist with audits/inspections of local clinical operations department and study/sites in the country.
• Continuously develop knowledge in GCP, internal company guidelines, SOPs, new monitoring technologies and capabilities.
• Lead or participate in regional/global clinical operations projects.
• 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.
• 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.

Preferred Qualifications

• Experience leading delivery across late phase and/or registrational cardiovascular, vaccines and/or steatotic liver disease studies is highly valued.
• 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.