Global Biomarker Studies Program Lead

Roche; Welwyn; Remote; GBP 70,000 - 100,000; Full time

Job summary

Roche in Welwyn 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 transformative medicines.

The role requires a life sciences degree and 3+ years in clinical operations or biomarker development, with strong collaboration and regulatory knowledge.

Qualifications

• University degree in life sciences or equivalent practical experience.
• 3+ years in clinical operations, biomarker/diagnostic development, or pharmaceutical R&D.
• Experience managing clinical study teams and external biomarker labs.
• Solid working knowledge of ICH-GCP and quality guidelines.

Responsibilities

• Lead end-to-end biomarker study operations with robust planning and data delivery.
• Manage vendor partnerships, budgets, and timelines for central and specialty biomarker labs.
• Drive cross-functional operational strategy with clinical study teams, translational scientists, data teams, and diagnostic partners.
• Contribute to core study design including protocols, ICFs, BMPs, and site workflow plans.
• Ensure regulatory excellence and compliance with ICH-GCP, ISO standards, and health authority guidelines.
• Foster continuous improvement and mentor teams in biomarker and sample handling workflows.

Skills

Cross-functional leadership

Vendor management

Biomarker operations

Regulatory knowledge

Clinical operations

Education

University degree in life sciences

Job description

Roche in Welwyn 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 transformative medicines.

The role requires a life sciences degree and 3+ years in clinical operations or biomarker development, with strong collaboration and regulatory knowledge.