Director, US Portfolio Delivery (cross-TA)

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

Benefits offered by this job

Health care benefits

Retirement benefits

Paid holidays

Vacation and leave

Job summary

GlaxoSmithKline seeks a Director, US Portfolio Delivery to oversee cross-TA study delivery, guiding US Program Leads and Local Delivery Leads to meet global R&D objectives with quality and compliance.

This role requires extensive clinical operations leadership, capacity planning, and collaboration with regional teams, vendors, and patient-focused partners to accelerate assets through late-stage development.

Qualifications

• University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent professional experience.
• 10+ years in clinical operations delivery, including multisite US studies.
• 5+ years leading clinical operations leaders in high-volume environments.

Responsibilities

• Lead a team of Program Leads and Local Delivery Leads in a complex, high-volume environment.
• Manage capacity and resourcing across countries to align with study needs.
• Ensure on-time delivery of all study management deliverables with quality.
• Identify best practices and standardize processes across LOC and regions.
• Recruit and develop LDLs; coordinate development plans for direct reports.

Skills

Agile Thinking

Business Acumen

Clinical Development

Clinical Trial Designs

Communication

Creativity

Decision Making

Fostering Collaboration

Good Clinical Practice

Influencing Without Authority

People Management

Pharmaceutical Industry

Project Management

Education

University degree in Sciences or related field

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

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

Key Responsibilities

• Leads a team of PLs and LDLs operating in a highly complex environment due to scale (number of subjects/sites per study) and volume of studies conducted, providing training, coaching, mentoring, line and performance management.
• Responsible for effectively managing capacity utilization of LDL resources and contributes to resourcing solutions including multi-country support by LDLs, 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 project management deliverables for all studies assigned to the LOC to agreed timelines, budget and quality standards. The LDL manager 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 LOC / region and representing local/regional clinical operations on global and cross functional initiatives. Ability to understand and respond to unique challenges in managing workload due to size and scale of studies.
• 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.
• In collaboration with Clinical Operation Director and Local/Regional Quality, Capability & Risk Manager identifies management monitoring process checks linked with LDL activities that require inclusion in the local quality plan to ensure quality and integrity of clinical studies conducted in the LOC.
• 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. Serves as an expert in ICH GCP and GSK written standards for LDLs.
• 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, multisite 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 highvolume, highcomplexity environment.

Preferred Qualifications

• Demonstrated accountability for study delivery to timelines, quality standards, and regulatory requirements, including risk identification, issue escalation, and problem resolution.
• Strong working knowledge of ICHGCP, 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.

#LI-GSK*

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. 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. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Why GSK?

Uniting 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. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/