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Title:: Associate Director, Global Study Lead
This position within GCSD (Global Clinical Study Delivery) is accountable for leading the operational strategy, planning and delivery of the study/studies end to end from CSI (Commit to Study Initiation) until study archiving to time, quality, budget, company standards and scientific requirements as outlined in the clinical development plan. The Associate Director, Global Study Lead (GSL) owns the vision for study success, the prioritization of deliverables and formation of Working Groups with key leadership across the matrix organization with the Study Level Statistician and Clinical Lead. The GSL represents Clinical Operations within the Study Leadership Team (SLT).
In this role you will:
Strategic study leadership & delivery: Accountable member of the Study Leadership Team (SLT) providing strategic leadership and decision‑making to deliver studies to time, quality, budget, scientific and company standards, including robust upfront feasibility, planning, governance preparation, and understanding study contribution to the broader program/submission.
Operational oversight, risk & issue management: Provides end‑to‑end operational oversight and support to Global Study Manager (GSM) and Study Manager(SM), acting as the escalation point for Clinical Operations, vendors, and working groups; proactively identifies, assesses, and mitigates study risks while balancing risk/benefit and ensuring effective issue resolution.
Compliance, quality & inspection readiness: Ensures compliance with ICH/GCP, applicable laws, regulations, and GSK SOPs; oversees protocol compliance, quality management, and continual inspection readiness, with strategic operational input into protocol, ICF, and key study documents.
Stakeholder communication & matrix leadership: Accountable for translating asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead and is escalation point for clinical operations, support the Working Groups leads to proactively and effectively identify, oversee, and mitigate study risks. Builds and leads empowered matrix teams, ensuring clear, timely stakeholder communication on study status, expectations, risks, and issues; provides therapeutic area expertise and contributes to ways of working and process improvement initiatives.
Financial & vendor accountability: Accountable for study budget and financial reviews; leads assessment, selection, and holistic oversight of FSO and other study vendors in collaboration with COAL, GSM, and SM, serving as escalation point for vendor performance and delivery issues.
Innovation, technology & efficiency: Drives innovative study delivery approaches (e.g., DCTs), acts as decision‑maker for study‑level innovation, and serves as an ambassador for AIML, automation, and digital tools to improve efficiency, quality, and ways of working across teams.
Why you?
Basic Qualifications & Skills: (We are looking for professionals with these required skills to achieve our goals):
Degree in life sciences, health informatics or a related field, or equivalent experience + extensive clinical development experience and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
Proven global study leadership experience, experience in leading global study set-up and delivery with multi-country execution, including leading high‑performing, cross‑functional matrix teams and driving timely, high‑quality decision‑making in complex and high‑pressure environments.
Strong knowledge of study management and regulatory requirements, including in‑depth understanding of ICH/GCP and global regulatory guidelines.
Demonstrated stakeholder management and influence skills, with the ability to engage, align, and influence senior leaders (Senior Director / VP level) and cross‑functional partners.
Excellent project and budget management capabilities, including proactive issue identification, risk mitigation, prioritization, and delivery against timelines and financial targets.
Highly developed communication, leadership, and collaboration skills, with the ability to articulate strategy, manage conflict, foster psychological safety, and empower others in a matrixed environment
Preferred Qualifications & Skills: (Please note the following skills are not necessary, just preferred, if you do not have them, please still apply):
Deep therapeutic area expertise, ideally consolidated within specific indications, with the agility to work across multiple therapeutic areas and study types.
Strategic leadership experience in innovative trial designs, including adaptive designs, decentralised clinical trials (DCTs), and exposure to platform, umbrella, or basket trials.
Extensive experience managing CROs and external vendors, including oversight of performance, realignment when delivery is at risk, negotiation of solutions, and leading After‑Action Reviews.
Experience with complex or adaptive study designs
Strong change leadership and growth mindset, with the creativity to modernize clinical delivery, leverage external technologies and networks, and continuously improve ways of working.
Proven ability to lead through influence, making timely, complex decisions with strong rationale, championing key decisions, and connecting teams to purpose.
Skills
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.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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