Description
GSK has bold ambitions to positively impact the health of 2.5 billion people by the end of the decade. The company's R&D focuses on discovering and delivering vaccines and medicines, combining understanding of the immune system with cutting-edge technology to transform people's lives.
Job Purpose The Director, US Portfolio Delivery (cross-TA) provides leadership, oversight, and local US delivery of studies in support of global R&D programs. The LDL-Director is accountable for a portfolio of assets and manages the activities of US Program Leads (PLs) and US Local Delivery Leads (LDLs) to ensure the delivery of all clinical studies across therapeutic areas to the required quality standards, GSK written standards, and ICH GCP.
Key Responsibilities:
- Leads a team of PLs and LDLs operating in a highly complex environment, providing training, coaching, mentoring, line and performance management.
- Manages capacity utilization of LDL resources and contributes to resourcing solutions, ensuring alignment of capabilities with study requirements, resource availability, and business priorities.
- Ensures completion of all project management deliverables for assigned studies to agreed timelines, budget, and quality standards.
- Identifies and shares best practices, standardizing across the LOC/region, and represents local/regional clinical operations on global and cross-functional initiatives.
- Recruits and develops LDLs, evaluates capabilities and competencies, and implements personal development plans.
- Partners with local and central teams to ensure robust study feasibility and establishes strategic relationships with external vendors.
- Ensures critical study timelines are accurately forecasted and achieved, and provides trouble-shooting and problem resolution support.
- Collaborates with Clinical Operation Director and Local/Regional Quality, Capability & Risk Manager to identify management monitoring process checks.
- Assists with audits/inspections and maintains continuous development of knowledge in GCP, internal company guidelines, and new monitoring technologies.
Basic Qualifications:
- University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology, or related fields) or equivalent demonstrable professional experience.
- 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.
Preferred Qualifications:
- Demonstrated accountability for study delivery to timelines, quality standards, and regulatory requirements.
- 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.
Benefits: The US annual base salary for new hires in this position ranges from $153,750 to $256,250. The position offers an annual bonus and eligibility to participate in the share-based long-term incentive program. Available benefits include healthcare and other insurance benefits, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
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