Director, US Portfolio Delivery – Cross-TA

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Oversee a team of Local Delivery Leads in a complex, high-volume setting

• Deliver training, coaching, mentoring, line management, and performance oversight

• Manage the capacity utilization of Local Delivery Leads, aligning their skills with study needs, resource availability, and business objectives

• Contribute to leadership teams overseeing clinical research within the US local operating company

• Ensure the timely completion of study deliverables within the designated portfolio, adhering to budget and quality standards

• Identify, address, or escalate risks and issues impacting study delivery

• Identify and disseminate best practices, standardizing operations across the US

• Represent local/regional clinical operations in global and cross-functional initiatives

• Recruit and nurture Local Delivery Leads, coordinating their personal development plans

• Collaborate with local and central teams on study feasibility, clinical facilities, and monitoring resources

• Establish and nurture strategic partnerships with external vendors

• Forecast and meet study timelines, recruitment targets, patient recruitment cycle times, data and audit quality, and site milestones

• Provide support for troubleshooting and problem resolution

• Assist with audits and inspections of local clinical operations and studies/sites in the US

• Maintain knowledge of GCP, internal guidelines, SOPs, monitoring technologies, and capabilities

• Lead or engage in regional/global clinical operations projects

⛳️ Requirements

• Bachelor’s degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology, or related fields) or equivalent demonstrable professional experience in the area

• A minimum of 10 years in clinical operations delivery within the pharmaceutical or biotech sectors, including leadership of complex, multi-site clinical studies in the US

• At least 5 years of experience in leading and developing clinical operations leaders or managers in a high-volume, high-complexity environment

• Proven accountability for study delivery in accordance with timelines, quality standards, and regulatory requirements

• Experience in risk identification, issue escalation, and problem resolution

• Strong understanding of ICH-GCP, GSK written standards, and US regulatory expectations

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

• Experience managing a portfolio of studies across multiple asset teams

• Proven track record in delivering clinical trials in the US, including studies with extensive site networks, intricate protocols, and competitive enrollment environments

• Willingness and availability to travel as required by the job

🏝️ Benefits

• Annual bonus

• Eligibility to participate in a share-based long-term incentive program

• Health care and additional insurance benefits for employees and their families

• Retirement benefits

• Paid holidays

• Vacation

• Paid caregiver/parental leave

• Paid medical leave

• Accommodation or other assistance for applicants, if required