Associate Director, Associate Clinical Operations Asset Lead (aCOAL)

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.
Find out more:
Our approach to R&D

Position Summary
You will support and lead operational delivery for complex oncology late clinical assets. You will work closely with EDT/MDT, Study Team and COAL to keep studies inspection ready and deliver high-quality, regulatory-grade data. We value clear decision making, collaborative leadership, and practical problem solving. This role offers strong growth, the chance to influence program strategy, and the opportunity to help GSK unite science, technology and talent to get ahead of disease together.

Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Lead and support the operational strategy and delivery for assigned late phase development streams, ensuring alignment with the clinical development plan.
• Coordinate cross-functional inputs from clinical, biostatistics, safety, clinical supplies and vendors to meet timelines and quality expectations.
• Represent DevOps at EDT/MDT.
• Contribute to protocol development, operational feasibility assessments and resourcing decisions, including insourcing versus outsourcing recommendations.
• Maintain inspection readiness and quality oversight, supporting risk management, mitigation plans and serious breach escalation when needed.
• Provide operational input for regulatory deliverables and governance forums, including scenario modelling and budget forecasting for clinical activities.
• Act as a point of contact for stakeholders and vendors to ensure consistent execution across studies and sub-projects.

Why You?

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Bachelor’s degree in life sciences, health sciences or equivalent qualification.
• Experience in oncology clinical development.
• Experience in vendor management and oversight of Contract Research Organization (CRO) relationships.
• Experience working in roles requiring application of Good Clinical Practice (GCP) and clinical development processes
• Experience delivering global study oversight across multiple regions.

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

• Experience managing multiple stakeholders and communicating in written and verbal English in a professional setting.
• Experience in Phase II-III programs.
• Working on complex, multi-indication programs.
• Experience in clinical operations, clinical project or program management.
• Experience contributing to regulatory submission content or supporting regulatory interactions.
• Experience with budgeting and forecasting for clinical studies.
• Familiarity with clinical supplies, bio-sample management or diagnostic implementation.
• Experience working in matrix teams and mentoring junior colleagues.

Working model
This role is hybrid. You will typically work 2 to 3 days per week onsite at a GSK office.

#GSK-LI

Skills

Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Cross-Departmental Collaboration, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Scientific Presentations

 

 

Polish Salary Range / Polski przedział wynagrodzenia: PLN 373,500 to PLN 622,500Italian Salary Range / Fascia retributiva in Italia: EUR 66,000 to EUR 110,000The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. 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 candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

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.

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/