Director, US Portfolio Delivery (cross-TA)

GSK; Upper Providence (Delaware County); On-site; USD 154,000 - 256,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid time off

Parental leave

Job summary

GSK in the United States seeks a Director of US Portfolio Delivery to provide leadership and oversight of clinical studies within a global R&D program. The LDL-Director manages US Program Leads and LDLs to ensure timely, quality study delivery in line with ICH GCP and GSK standards.

The role requires a university degree in sciences, 10+ years in clinical operations, and proven leadership across multi-site studies in the US.

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 in a high-volume, high-complexity environment.
• 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.

Responsibilities

• Lead a team of LDLs operating in a highly complex environment due to scale and number of US studies conducted.
• Provide training, coaching, mentoring, line and performance management.
• Manage capacity utilization of LDLs aligning capabilities with study requirements and business priorities.
• Ensure completion of all deliverables for studies within assigned portfolio to timelines, budget and quality standards.
• Identify and resolve risks and issues impacting study delivery.
• Develop best practices and standardize processes across US operations.
• Recruits and develops LDLs and evaluates staff capabilities.
• Travel as required by the role.

Skills

Leadership

Clinical operations

Strategic thinking

Risk management

People management

Project management

Communication

Budgeting

Education

University degree in Sciences or equivalent

Job 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. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Job Purpose

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. The LDL‑Director operates independently and effectively in a highly complex, high volume, strategic market.

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.
• The LDL‑Director works with the LDLs to identify and resolve or elevate risks and issues that may impact study delivery.
• 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.
• Provides trouble‑shooting and problem resolution support for LDLs to ensure productive, efficient study delivery.
• 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.

Skills Agile Thinking, Business Acumen, Clinical Development, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, People Management, Pharmaceutical Industry, Project Management

The US annual base salary for new hires in this position ranges from $153,750 to $256,250.

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.

If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail].

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Why GSK?

Unite science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together – to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.