Associate Director, Bioanalytical Strategy & Biomarkers

CSL Ltd. ADR; Waltham (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

CSL Behring in the United States seeks a senior bioanalytical and biomarker leader to guide strategic development of PK/ADA assays, supporting nonclinical and clinical programs.

The role requires directing external execution and ensuring regulatory-compliant data delivery, with strong leadership and collaboration across cross-functional teams.

PhD in Life Sciences and 5–10 years of relevant experience, plus exceptional communication and project management skills, are essential.

Qualifications

• Postgraduate degree (PhD) in bioanalytical sciences or related field.
• Minimum of 5–10 years of industry or academic experience in clinical biomarker/bioanalytical assays.
• Strong leadership of cross-functional teams across international collaborations.
• Deep understanding of regulatory guidance and industry best practices.
• Excellent communication and data interpretation skills.
• Experience managing external partners and vendors.

Responsibilities

• Develop and implement bioanalytical/biomarker strategies to support clinical bioanalysis.
• Lead and mentor scientists across functional groups.
• Oversee external due diligence and advisory on assay data and regulatory readiness.
• Drive progression of projects from nonclinical to clinical development.
• Direct strategy for externalisation of bioassays to vendors.
• Optimize workflows, budgets, and resource allocation.
• Provide scientific guidance across Clinical Bioanalytics and Biomarkers.
• Ensure regulatory-compliant study design and data analysis.
• Represent CSL at conferences and with collaborators.

Skills

Team leadership

Cross-functional leadership

Regulatory guidance

Data analysis

Scientific communication

External partnerships

Biomarker assays

Project governance

Education

PhD in Life Sciences

Job description

CSL Behring in the United States seeks a senior bioanalytical and biomarker leader to guide strategic development of PK/ADA assays, supporting nonclinical and clinical programs.

The role requires directing external execution and ensuring regulatory-compliant data delivery, with strong leadership and collaboration across cross-functional teams.

PhD in Life Sciences and 5–10 years of relevant experience, plus exceptional communication and project management skills, are essential.