Clinical Operations Asset Lead, Director

Business Introduction

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.

Position Summary

The Clinical Operations Asset Lead is the single point of accountability for clinical operations delivery across the full asset lifecycle. Representing Global Clinical Operations at the asset level, the COAL sets and delivers the program level operational strategy that enables execution of the scientific vision.

Working in close partnership with clinical, biostatistics, and functional experts, the COAL drives informed decision making, provides strategic leadership to Study Delivery Teams, and ensures high quality, on time delivery-while retaining full accountability for overall asset outcomes.

Key Responsibilities Asset & Development Strategy

• Contribute to the Clinical Development Plan (CDP) and Integrated Evidence Plan (IEP) across Research, Development, and LCM
• Ensure study designs are operationally feasible, regionally compliant, cost effective, and deliver high quality data
• Provide protocol level operational input and support amendments through governance review

Resourcing & Vendor Strategy

• Lead and own the asset level resourcing strategy (in house vs outsourced)
• Approve vendor selection, contracting, and oversight in line with GSK standards

Delivery Quality & Inspection Readiness

• Serve as escalation point for critical operational, quality, and GCP issues
• Lead cross functional coordination to ensure inspection readiness and high quality study delivery
• Ensure transparent communication of risks, issues, and successes across GCO

Operational Delivery & Governance

• Own asset level delivery plans, scenario modeling, and budget forecasts
• Drive innovative, patient centric and efficient approaches to study execution
• Represent Clinical Operations at governance boards and support clinical filing activities

Risk, Data & Stakeholder Management

• Own the asset level risk register and mitigation strategy using Quality by Design
• Ensure accurate, current operational data in GSK systems until transition to study teams
• Lead internal and external stakeholder engagement across the asset

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in general science or life/health related Science Degree
• Extensive portfolio level strategic experience leading and delivering complex clinical research programs or equivalent initiatives with significant business impact.
• Expert level experience across end to end clinical development and the regulatory landscape, enabling proactive, innovative strategic guidance and independent leadership of complex cross functional teams.
• Proven experience navigating and strategizing across multiple regulatory pathways potentially pursued simultaneously for different indications.
• Ability to develop and execute integrated strategic plans across multiple streams and indications for one large asset or multiple interdependent assets.
• Excellent leadership skills building and managing matrixed teams, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives within highly complex and high pressure environments, while maintaining visibility at a senior level.
• Excellent influencing and stakeholder management skills at all levels of the organization (including SVP and C level).
• Competent in working with complexity and uncertainty within the external regulatory environment (e.g. FDA, EMEA).

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Masters's Degree in General Science or life/health related Science Degree or MBA
• Preferred experience leading or contributing to operational integration aspects of BD deals
• Demonstrated cross functional collaborator with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization.

The annual base salary in Poland for new hires in this position ranges from PLN 437,250 to PLN 728,750 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. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. 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.

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.