US Local Delivery Lead Director

GlaxoSmithKline; United States; Remote; USD 170,000 - 283,000; Full time

Benefits offered by this job

Health care benefits

Retirement benefits

Paid holidays

Vacation

Paid caregiver/parental and medical-le

Job summary

GlaxoSmithKline seeks a US Local Delivery Lead Director to oversee LDLs delivering multiple complex, multi-site clinical studies across therapy areas, ensuring quality, timelines and budget alignment.

The role requires strong GCP knowledge, 10+ years in clinical operations in pharma, and proven leadership of high‑volume studies in the US; occasional travel is expected as studies require.

Qualifications

• Strong knowledge of ICH-GCP and US regulatory expectations.
• Experience leading multi-site oncology or complex studies is preferred.

Responsibilities

• Lead a team of LDLs in complex, high-volume clinical studies in the US.
• Ensure study timelines, budget and quality standards are met.

Skills

Agile Thinking

Business Acumen

Clinical Development

Project Management

Clinical Operations

Leadership

Education

University degree in Sciences

10+ years clinical operations experience

Job description

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

US Local Delivery Lead Director provides leadership, oversight and manages the activities of local delivery leads (LDLs) to ensure the delivery of all clinical studies, across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards and ICH GCP. Operates independently and effectively in a highly complex, high volume, strategic market.

Key Responsibilities

• Leads a team of LDLs operating in a highly complex environment due to scale (number of subjects/sites per study) and volume (number of studies assigned to country) 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‑shouting 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, 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

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 ICH-GCP, GSK written standards, and US regulatory expectations
• Experience delivering oncology clinical trials in the US, including studies with large site networks, complex protocols, and competitive enrollment environments
• Experience leading delivery across late phase and/or registrational oncology studies is highly valued
• Familiarity with oncology specific operational challenges, such as:
• High protocol complexity and amendment frequency
• Specialized site types and networks
• Competitive enrollment and site capacity constraints
• Experience operating across multiple oncology indications or programs within a portfolio

Skills

• Agile Thinking
• Business Acumen
• Clinical Data Management
• Clinical Development
• Clinical Research
• Clinical Trials
• Communication
• Creativity
• Decision Making
• Pharmaceutical Industry
• Project Management

Salary & Benefits

The US annual base salary for new hires in this position ranges from $169,500 to $282,500. 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.

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave

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.

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].

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.

Company Culture

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.