Senior Bioanalytical Strategy & Biomarker Programs Lead

CSL Vifor; Waltham (MA); On-site; USD 170,000 - 210,000; Full time

Job summary

CSL Vifor is seeking a senior leader to oversee bioanalytical and biomarker assays supporting nonclinical and clinical studies in our Waltham, MA team. The incumbent will guide external execution of assays, ensure regulatory compliance, and influence study design with internal stakeholders.

The role requires a PhD-level background, 5–10 years in biomarker analytics, and proven ability to manage cross-functional, international teams while driving innovation and data quality for submissions.

Qualifications

• Postgraduate degree (preferably PhD) with extensive biomarker/bioanalytical assay experience.
• 5–10 years of industry or academic lab leadership in bioanalytical research.
• Strong scientific background in Life Sciences.
• Proven ability to lead cross-functional, international teams.
• Deep understanding of regulatory guidance and best practices.
• Excellent analytical and communication skills.

Responsibilities

• Lead external bioanalytical/biomarker strategies with regulatory compliance.
• Direct progression from nonclinical to clinical development, including submissions.
• Manage externalisation of critical bioassays and vendor transfers.
• Optimize workflows, budgets, and resource allocation.
• Provide scientific oversight across the Clinical Bioanalytics and Biomarkers function.
• Represent CSL R&D at conferences and collaborations.

Skills

Leadership

Regulatory knowledge

Analytical skills

Communication

Cross-functional collaboration

Team management

Vendor management

Education

PhD in Life Sciences

Tools

AI in regulated environments

Job description

CSL Vifor is seeking a senior leader to oversee bioanalytical and biomarker assays supporting nonclinical and clinical studies in our Waltham, MA team. The incumbent will guide external execution of assays, ensure regulatory compliance, and influence study design with internal stakeholders.

The role requires a PhD-level background, 5–10 years in biomarker analytics, and proven ability to manage cross-functional, international teams while driving innovation and data quality for submissions.