Site Name: Belgium-Wavre, GSK HQ, Italy - Siena, UK - Hertfordshire - Stevenage, Warsaw Rzymowskiego 53
Position Summary
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. The Global Study Lead owns the vision for study success, prioritises deliverables, forms Working Groups with key leadership across the matrix organization and represents Clinical Operations within the Study Leadership Team.
Responsibilities
* Strategic study leadership & delivery: Provide 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: Provide end‑to‑end operational oversight and support to Global Study Manager and Study Manager, act as escalation point for Clinical Operations, vendors, and working groups; proactively identify, assess, and mitigate study risks while balancing risk/benefit and ensuring effective issue resolution.
* Compliance, quality & inspection readiness: Ensure compliance with ICH/GCP, applicable laws, regulations, and GSK SOPs; oversee protocol compliance, quality management, and continual inspection readiness, with strategic operational input into protocol, ICF, and key study documents.
* Stakeholder communication & matrix leadership: Translate asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead, support Working Group leads, and build and lead empowered matrix teams, ensuring clear, timely stakeholder communication on study status, expectations, risks, and issues.
* Financial & vendor accountability: Accountable for study budget and financial reviews; lead 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: Drive innovative study delivery approaches (e.g., DCTs), act as decision‑maker for study‑level innovation, and serve as an ambassador for AIML, automation, and digital tools to improve efficiency, quality, and ways of working across teams.
Basic Qualification
* 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 Qualification
* 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 modernise 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.
Salary & Benefits
The annual base salary in Poland for new hires in this position ranges from PLN 339,750 to PLN 566,250 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non‑discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
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