About this Director, Clinical Operations Asset Lead Oncology role at GSK
Role Summary:
The Clinical Operations Asset Lead represents all Development Operations functions at the asset level and at Early Development Team (EDT) or Medicine Development Team (MDT) and other asset team interactions and is accountable for developing the program level operational strategy and delivery plan to execute the scientific strategy for an asset and, working in partnership with clinical / biostats / clinical supplies and the functional subject matter experts to ensure informed asset decision-making from the operational, scientific and data perspectives.
Key Responsibilities:
Lead and support the operational strategy and delivery for assigned early phase oncology programs and/or late phase development programs, ensuring alignment with the clinical development plan.
Represent Development Operations at EDT/MDT.
Coordinate cross-functional inputs from clinical, biostatistics, safety, clinical supplies and vendors to meet timelines and quality expectations.
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.
Basic Qualification:
Bachelor’s degree in life sciences, health sciences or equivalent qualification.
Experience in oncology clinical operations (both solid tumours and haemato-oncology).
Experience in oncology early-phase development (FiH/Ph1).
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 clinical program oversight across multiple regions.
Ability to manage multiple stakeholders and communicate effectively in written and verbal English in a professional setting.
Preferred Qualification:
Experience working on complex, multi-indication programs.
Experience in phase 1 healthy volunteer studies.
Formal project management training or certification.
Experience contributing to regulatory submission content or supporting regulatory interactions.
Experience with budgeting and forecasting for clinical studies and programs.
Familiarity with clinical supplies, bio-sample management or diagnostic implementation.
Experience working in matrix teams and mentoring junior colleagues.
Work Arrangement:
This role offers a hybrid working model, with a mix of on-site and remote work.
Closing date for applications is Monday 28th September
Skills
Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations
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.
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