Biomarker Studies Program Lead - Global Clinical Ops

Roche; Welwyn Hatfield; On-site; GBP 65,000 - 100,000; Full time

Job summary

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.

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.

Skills

Biomarker operations

Vendor management

Cross-functional collaboration

Clinical study support

Education

Life sciences degree

Job description

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.