Director, US Portfolio Delivery (cross-TA)

GSK • Upper Providence, PA

4d • $153,750 - $256,250

About The Position

The Director of US Portfolio Delivery, also referred to as the US Local Delivery Lead Director, provides leadership, oversight, and local US delivery of studies supporting global R&D programs. The role is accountable for a portfolio of assets and manages US Program Leads and US Local Delivery Leads to ensure 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 role leads and develops Local Delivery Leads, manages capacity and capabilities against study needs and business priorities, and contributes to clinical research leadership within the local operating company. The Director is accountable for completing portfolio study deliverables on time, within budget, and to quality standards; identifies and resolves or escalates delivery risks; and supports feasibility, vendor relationships, recruitment, study milestones, audits, and inspections. The Director also shares best practices, represents local and regional clinical operations in global initiatives, and leads or participates in clinical operations projects. 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 Clinical Trial Managers, 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.
• Willingness and availability to travel as required.

Nice To Haves

• Experience leading delivery of late-phase and/or registrational studies in cardiovascular disease, vaccines, and/or steatotic liver disease.
• Experience leading delivery of a portfolio of studies across multiple asset teams.
• Experience delivering US clinical trials involving large site networks, complex protocols, and competitive enrollment environments.

Responsibilities

• Lead a team of Local Delivery Leads in a complex environment involving large numbers of subjects, sites, and US studies; provide training, coaching, mentoring, line management, and performance management.
• Manage Local Delivery Lead capacity and align capabilities with study requirements, resource availability, and business priorities.
• Contribute to clinical research management within the local operating company through participation in applicable leadership teams, supporting consistency, resource utilization, and best practices.
• Ensure completion of deliverables for studies in the assigned portfolio 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 practices across the US, and represent local and regional clinical operations in global and cross-functional initiatives.
• Recruit and develop Local Delivery Leads; assess internal staff capabilities and competencies and coordinate personal 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 appropriately resourced and executed.
• Ensure accurate forecasting and achievement of critical study timelines, recruitment targets, patient recruitment cycle times, data and audit quality, and site-related milestones.
• Provide troubleshooting and problem-resolution support to Local Delivery Leads to enable productive and efficient study delivery.
• Assist with audits and inspections of local clinical operations, studies, and sites as required.
• Continuously develop knowledge of GCP, internal company guidelines and SOPs, and new monitoring technologies and capabilities.
• Lead or participate in regional and 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, depending on role level.
• Health care and other insurance benefits for employees and their families.
• Retirement benefits.
• Paid holidays.
• Vacation.
• Paid caregiver, parental, and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director