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At Roche, we're driven by the conviction that great medicines can transform lives. Our Pharma Product Development Global Clinical Operations (PDG) team is focused on realizing our Pharma Ambition to deliver 20 transformative medicines by 2029, addressing diseases with the highest societal burden. Join us as a Biomarker Studies Asset Manager and you'll be instrumental in leading and driving the operational delivery of biomarker studies for one or more of our critical molecule assets, ensuring operational excellence and strategic execution.
The Opportunity
Your primary purpose will be to ensure the consistent, end-to-end operational planning and execution of study-level biomarker strategies across clinical and investigational device/CDx studies.
Lead the planning and execution of all end-to-end study-level biomarker operations activities, including risk identification and mitigation.
Manage central and specialty biomarker laboratories/vendors, encompassing project scope, budget, and timelines, while guaranteeing high-quality delivery.
Collaborate actively with Science and Data functions to coordinate biomarker data requirements and delivery timelines, ensuring quality data input.
Serve as the single point of contact for biomarker/IVD operations, expertly partnering with cross-functional stakeholders (e.g., translational science, CDx, central lab) to execute operational strategies.
Develop and oversee biomarker analysis timelines, budget, risk, compliance, and quality, ensuring strict adherence to ICH/GCP, SOPs, and regulatory requirements.
Provide technical knowledge on biomarker analyses, including sample collection/handling, assay, device, and imaging technologies, to both internal and external stakeholders.
Who you are
You are a self-starter with a passion for achieving successful outcomes and a desire to make a difference in drug development. You thrive in fast-paced, ambiguous and collaborative environments and possess a growth mindset.
Proven experience in a clinical research/operations setting, clinical/diagnostic development, or pharmaceutical/biotechnology R&D.
Possess a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
Strong experience with vendor and project management.
Possess strong knowledge of the drug development process and respective regulations, including ICH, GCP, and associated ISO standards.
Clinical development experience with evidence of working in teams running clinical studies is desirable
Excellent collaboration, communication, influencing, and presentation skills.
Fluency in English is required.
A university degree or equivalent years of experience, with a preferred focus in life sciences is preferred.
This role is based onsite at our Welwyn, United Kingdom office. Our team follows a hybrid work structure.
Relocation benefits are not available for this job posting.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.