Senior Bioanalytical & Biomarker Strategy Lead

CSL Plasma Inc.; Waltham (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

CSL Behring is seeking a senior leader in bioanalytical and biomarker assays to guide clinical bioanalysis strategy and externalization with external vendors. You will lead cross‑functional teams, ensure regulatory compliance, and advance assay development across nonclinical and clinical programs.

The role requires a PhD with 5–10 years of industry experience, deep knowledge of PK/ADA and biomarker platforms, and strong communication to influence stakeholders and drive project success.

Qualifications

• Postgraduate degree (PhD) in Life Sciences or related field.
• Minimum 5–10 years of relevant industry experience in clinical bioanalysis or biomarker assays.
• Strong understanding of regulatory guidance and industry best practices; ability to lead cross-functional teams.

Responsibilities

• Develop and implement bioanalytical/biomarker strategies to support clinical bioanalysis and program goals.
• Lead and mentor scientists across functional groups; manage externalization with vendors.
• Ensure regulatory compliance, data quality, and clinical submission readiness; manage risks.

Skills

Biomarker assays

Bioanalytical leadership

Regulatory knowledge

Cross-functional leadership

External partner management

Data analysis

Scientific mentoring

Communication skills

Education

PhD or equivalent in Life Sciences

Job description

CSL Behring is seeking a senior leader in bioanalytical and biomarker assays to guide clinical bioanalysis strategy and externalization with external vendors. You will lead cross‑functional teams, ensure regulatory compliance, and advance assay development across nonclinical and clinical programs.

The role requires a PhD with 5–10 years of industry experience, deep knowledge of PK/ADA and biomarker platforms, and strong communication to influence stakeholders and drive project success.