Biomarker Studies Asset Manager (BSAM)

2703 Roche Products Limited; Welwyn Hatfield; Sur place; GBP 65 000 - 100 000; Plein temps

Résumé du poste

Roche in Welwyn Hatfield is seeking a Biomarker Studies Asset Manager to lead end-to-end biomarker operational strategies across global trials. You will bridge science, clinical operations, and diagnostic partnerships to ensure high-quality data delivery that accelerates medicines for patients.

You will shape study design, manage vendor relationships, and ensure regulatory excellence under ICH/GCP and ISO standards while mentoring team members in sample handling workflows.

Qualifications

• 3+ years in clinical operations, biomarker/diagnostic development, or pharmaceutical R&D.
• Experience with clinical study teams and biomarker workflows.
• Experience managing external specialty labs and vendor budgets.

Responsabilités

• Lead biomarker study operations: Direct end-to-end operational planning, risk mitigation, and high-quality data delivery for clinical trial and investigational device/companion diagnostic (CDx) studies.
• Manage vendor partnerships: Oversee scope, budgets, and timelines for central and specialty biomarker laboratories, ensuring rigorous performance and data integrity.
• Drive cross-functional operational strategy: Partner with clinical study teams, translational scientists, data teams, and diagnostic partners as the primary operational point of contact.
• Contribute to core study design: Shape protocols, Informed Consent Forms (ICFs), Biomarker Management Plans (BMP), and testing site operational plans.
• Ensure regulatory excellence: Safeguard study compliance under ICH/GCP, ISO standards, and relevant health authority guidelines, handling regulatory inquiries with technical precision.
• Foster continuous improvement: Champion operational best practices, refine processes, and mentor team members in biomarker and sample handling workflows.

Connaissances

Biomarker operations

Vendor management

Cross-functional collaboration

Clinical study support

Formation

Life sciences degree

Description du poste

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

As the Biomarker Studies Asset Manager, you lead and deliver end-to-end biomarker operational strategies for key molecule assets across global clinical trials. You bridge science, clinical operations, and diagnostic partnerships to ensure high-quality biological sample data delivery that directly accelerates transformative medicines for patients.

Responsibilities

• Lead biomarker study operations: Direct end-to-end operational planning, risk mitigation, and high-quality data delivery for clinical trial and investigational device/companion diagnostic (CDx) studies.
• Manage vendor partnerships: Oversee scope, budgets, and timelines for central and specialty biomarker laboratories, ensuring rigorous performance and data integrity.
• Drive cross-functional operational strategy: Partner with clinical study teams, translational scientists, data teams, and diagnostic partners as the primary operational point of contact.
• Contribute to core study design: Shape protocols, Informed Consent Forms (ICFs), Biomarker Management Plans (BMP), and testing site operational plans.
• Ensure regulatory excellence: Safeguard study compliance under ICH/GCP, ISO standards, and relevant health authority guidelines, handling regulatory inquiries with technical precision.
• Foster continuous improvement: Champion operational best practices, refine processes, and mentor team members in biomarker and sample handling workflows.

Who You Are

You bring curiosity, collaborative leadership, and a passion for turning complex biological science into structured clinical outcomes. You thrive in dynamic, cross-functional global team environments and believe in doing meaningful work that transforms healthcare.

Education & Experience

• University degree in life sciences (or equivalent practical experience) with 3+ years in clinical operations, biomarker/diagnostic development, or pharmaceutical R&D.

Clinical Operations Acumen

• Practical experience working within clinical study teams, managing clinical protocols, biological sample workflows, or laboratory vendors.

Project & Vendor Management

• Proven ability to manage project scope, timelines, external specialty labs, and operational budgets effectively.

Regulatory & Quality Foundation

• Solid working knowledge of clinical drug development standards, including ICH-GCP and relevant quality guidelines.

Collaborative Mindset

• Strong communication, presentation, and relationship-building skills across multidisciplinary global teams.

Who we are

Together, we’ll advance along the whole patient journey with the aspiration to prevent, stop and cure diseases. We are 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.