Associate Director, Local Delivery Lead/Local Trial Manager

GSK

14d•$129,750 - $216,250•Hybrid

About The Position

The Associate Director, Local Delivery Lead/Local Trial Manager provides end‑to‑end leadership for US clinical study delivery, serving as the primary operational link between global study teams and local US operations. It is accountable for achieving recruitment (including patient representation), timelines, budget, quality, and regulatory compliance while leading a highly matrixed, cross‑functional team of internal stakeholders, vendors, and investigative sites. The role drives proactive risk management, continuous improvement, and high‑quality decision‑making while acting as a trusted leader, coach, and GCP subject‑matter expert.

Requirements

Bachelor’s degree: BA or BS
7+ years’ experience as a clinical trial manager/local delivery lead managing studies and at least 4 of the years managing Medicines trials.
Must have Phase I-III Medicines trial experience in Respiratory, Immunology and/or Inflammation.
Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug development process.
Experience with leading and managing multiple complex design studies

Nice To Haves

Master of Science, PhD or equivalent coupled with previous project management experience.
Effective problem solving, negotiation and conflict resolution skills in a matrix environment
Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and adapts to these changes quickly and efficiently.
Deep knowledge of human research regulations in the US, IND/GCP/ICH-guidelines and GSK SOP/POL/guidelines
Available and willing to travel as job requires.
Strong written and verbal communications skills are required.

Responsibilities

Leads the local study team consisting of US clinical operations team members, cross functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery, providing both matrix leadership and project management of study activities within the United States.
Serves as the operational point-of-contact between the central GSK study team and US study team. Collaborate closely with local medical and regulatory affairs staff to align local medical and scientific requirements, IND/GCP/ICH guidelines.
Accountable for delivery of a portfolio of studies to recruitment targets, patient representation targets, time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations.
Acquires and maintains an appropriate level of knowledge on a disease area(s), aligned protocols, pathology of disease area, competitive landscape within the US, local treatment guidelines and local health care system requirements.
Demonstrates the ability to leverage AI and digital tools to solve complex problems, streamline processes, improve decision-making, and enhance efficiency for both individual work and broader team operations.
Proactively identifies, resolves, and/or escalates risks and issues that may impact the portfolio/disease area providing effective troubleshooting and problem‑resolution support to ensure efficient and productive portfolio execution.
Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity.
Has the curiosity to understand the why and the courage to challenge the how.
Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
Recognizes and reacts to changes that impact a study and/or program and has the skill set to assess the appropriateness of protocol/plans in the local environment.
Provides timely feedback to team members to support performance and development needs.
Stakeholder management skills required as the role includes interactions with internal senior leadership and external clinical site staff.
Demonstrates track record in quality decision-making and problem resolution. Able to set and manage priorities, resource and performance targets of local study deliverables. As required, assists with audits/inspections of local clinical operations department and study / sites in the US.
Takes a leadership role in standardizing processes, identifying and sharing best practices in support of continuous improvement. Represents local/regional clinical operations on global and cross functional initiatives. May serve in a subject matter expert (SME) capacity locally/globally.
Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards