Description
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.
The Director of US Portfolio Delivery (“US Local Delivery Lead Director”) 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 clinical studies to the required quality standards, GSK written standards and ICH GCP.
Key Responsibilities:
- Lead a team of LDLs operating in a highly complex environment due to scale (number of subjects/sites per study) and number of US studies conducted. Provide training, coaching, mentoring, line and performance management.
- Responsible for effectively managing capacity utilization of LDL ensuring alignment of capabilities with study requirements, resource availability and business priorities.
- Contribute to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilization of resources and best practice.
- Accountable for ensuring the completion of all deliverables for studies within assigned portfolio to agreed timelines, budget and quality standards.
- Responsible for identifying and sharing best practices, standardizing across the US and representing local/regional clinical operations on global and cross functional initiatives.
- Recruits and develops LDLs. Evaluates capabilities and competencies of internal staff, identifies and coordinates implementation of personal development plans for direct reports.
- Partners with local and central teams to ensure robust study feasibility with reference to study complexity, clinical facilities and monitoring resource.
- Establishes and manages key strategic relationships with external vendors to ensure clinical studies are appropriately resourced and executed as necessary.
- Ensures that critical study timelines related to study activities are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met.
- Assists with audits/inspections of local clinical operations department & study / sites in the country, as required.
- Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring technologies and capabilities.
- Leads or participates in regional/global clinical operations projects (as appropriate).
- Available and willing to travel as job requires.
Basic Qualifications:
- 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 (e.g., LDLs, study managers, CTMs) 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.
Preferred Qualifications:
- 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.
The US annual base salary for new hires in this position ranges from $153,750 to $256,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.