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

• Provide leadership, oversight and local US delivery of studies supporting global R&D programs • Manage activities of US Program Leads and US Local Delivery Leads across therapeutic areas • Lead, train, coach, mentor and performance-manage clinical operations leaders • Manage capacity utilization and contribute to resourcing solutions, including multi-country support • Ensure completion of project management deliverables to agreed timelines, budget and quality standards • Identify, resolve and escalate risks and issues affecting study delivery • Identify and share best practices and 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 • Establish and manage strategic relationships with external vendors • Forecast and achieve study timelines, recruitment targets, data and audit quality, and site milestones • Support monitoring process checks and local quality plans • Assist with audits and inspections of local clinical operations, studies and sites • Maintain expertise in GCP, company 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, including risk identification, issue escalation, and problem resolution • Strong working knowledge of ICH-GCP, GSK written standards, and US regulatory expectations • Experience delivering HIV, respiratory and/or hepatology clinical trials in the US • Experience working with site networks and referral networks • Experience partnering with Patient Advocacy Groups • Experience leading delivery across late phase and/or registrational studies • 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 and medical leave