Director, US Portfolio Delivery – cross-TA

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

📋 Description

• Provide leadership and oversight for the local delivery of studies that support global R&D initiatives in the US.

• Oversee the activities of US Program Leads and Local Delivery Leads across various therapeutic areas.

• Guide, train, coach, mentor, and manage the performance of clinical operations leaders.

• Manage capacity utilization and assist in developing resourcing solutions, including support across multiple countries.

• Ensure that project management deliverables are completed within agreed timelines, budgets, and quality standards.

• Identify, address, and escalate risks and issues that may impact study delivery.

• Share best practices and represent local/regional clinical operations in global and cross-functional initiatives.

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

• Collaborate with local and central teams to assess study feasibility.

• Establish and maintain strategic relationships with external vendors.

• Forecast and meet study timelines, recruitment goals, data quality, and site milestones.

• Support monitoring process checks and the implementation of local quality plans.

• Assist with audits and inspections related to local clinical operations, studies, and sites.

• Maintain expertise in GCP, company guidelines, SOPs, and monitoring technologies and capabilities.

• Lead or contribute to regional and global clinical operations projects.

⛳️ Requirements

• A university degree in Sciences (such as Medicine, Pharmacy, Biochemistry, Biology, or related fields) or equivalent professional experience in the area.

• A minimum of 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 in leading and developing clinical operations leaders or managers in a high-volume, high-complexity setting.

• Proven accountability for study delivery in accordance with 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 in delivering clinical trials related to HIV, respiratory, and/or hepatology in the US.

• Familiarity with site networks and referral networks.

• Experience collaborating with Patient Advocacy Groups.

• Proven track record in leading the delivery of late-phase and/or registrational studies.

• Willingness and availability to travel as required by the job.

🏝️ Benefits

• Annual bonus.

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

• Health care and other insurance benefits for employees and their families.

• Retirement benefits.

• Paid holidays.

• Vacation time.

• Paid caregiver/parental and medical leave.