Clinical Operations Asset Lead, Director at GSK

Mississauga, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

04 Aug, 26

Salary

728750.0

Posted On

06 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations Strategy, Clinical Development Plan, Vendor Management, GCP Compliance, Risk Management, Stakeholder Management, Budget Forecasting, Regulatory Strategy, Cross-functional Leadership, Inspection Readiness, Quality by Design, Matrix Team Management

Industry

Pharmaceutical Manufacturing

Description

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 Why you? 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. #LI-GSK* 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. 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. 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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the Link where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. 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.

Responsibilities

The Clinical Operations Asset Lead is accountable for the operational delivery and strategy across the full asset lifecycle. This includes managing resourcing, vendor selection, and ensuring high-quality, on-time delivery of clinical research programs.