Director, US Portfolio Delivery – Cross-TA

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $153.8k - $256.3k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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GSK

WebsiteLinkedInAll Job Openings

10,000+ employees

🏭 Manufacturing

💊 Pharmaceuticals

🏥 Healthcare

Manufacturing • Pharmaceuticals • Healthcare

GSK is a global healthcare company focused on uniting science, technology, and talent to advance pharmaceutical products and vaccines. With a commitment to innovation, GSK aims to provide solutions that help manage and prevent diseases, improving health outcomes for patients worldwide.

📋 Description

• Lead a team of Local Delivery Leads in a highly complex, high-volume environment • Provide training, coaching, mentoring, line management, and performance management • Manage Local Delivery Lead capacity utilization and align capabilities with study requirements, resource availability, and business priorities • Contribute to leadership teams managing clinical research within the US local operating company • Ensure completion of study deliverables within the assigned portfolio to agreed timelines, budget, and quality standards • Identify, resolve, or escalate risks and issues affecting study delivery • Identify and share best practices and standardize practices across the US • Represent local/regional clinical operations on global and cross-functional initiatives • Recruit and develop Local Delivery Leads and coordinate personal development plans • Partner with local and central teams on study feasibility, clinical facilities, and monitoring resources • Establish and manage strategic relationships with external vendors • Forecast and achieve study timelines, recruitment targets, patient recruitment cycle times, data and audit quality, and site milestones • Provide troubleshooting and problem-resolution support • 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 participate in regional/global clinical operations projects

🎯 Requirements

• 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 in a high-volume, high-complexity environment • Demonstrated accountability for study delivery to timelines, quality standards, and regulatory requirements • Experience with 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 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 • Available and willing to travel as job requires

🏖️ Benefits

• Annual bonus • Eligibility to participate in share-based long-term incentive program • Health care and other insurance benefits for employee and family • Retirement benefits • Paid holidays • Vacation • Paid caregiver/parental leave • Paid medical leave • Accommodation or other assistance to apply, if required