Senior Bioanalytical Strategy Lead, Clinical Assays

CSL; Waltham (MA); Sur place; USD 180 000 - 280 000; Plein temps

Résumé du poste

CSL in Waltham, MA, seeks a senior leader in bioanalytical and biomarker assays to guide nonclinical and clinical studies. You will shape strategies, oversee external execution, ensure regulatory compliance, and drive scientific excellence across programs.

You will mentor cross‑functional teams, manage vendor relationships, and communicate complex results to stakeholders, with a deep understanding of assay design, platforms, and clinical submission readiness.

Qualifications

• PhD required with extensive experience in clinical biomarker/bioanalytical assays.
• 5–10 years of relevant industry or academic experience.
• Strong scientific background in Life Sciences.
• Proven ability to manage cross-functional, multicultural teams.
• Deep understanding of regulatory guidance and industry best practices.
• Excellent written and verbal communication skills.

Responsabilités

• Lead external tactical execution of bioanalytical/biomarker assays for nonclinical and clinical studies.
• Develop and implement bioanalytical/biomarker strategies aligned with CSL goals.
• Mentor and lead scientists across functional groups to foster innovation and excellence.
• Direct strategy for externalisation and management of vendor relationships and data quality.

Connaissances

Bioanalytical leadership

Regulatory knowledge

Cross-functional leadership

Data interpretation

Communication

Formation

PhD

Description du poste

CSL in Waltham, MA, seeks a senior leader in bioanalytical and biomarker assays to guide nonclinical and clinical studies. You will shape strategies, oversee external execution, ensure regulatory compliance, and drive scientific excellence across programs.

You will mentor cross‑functional teams, manage vendor relationships, and communicate complex results to stakeholders, with a deep understanding of assay design, platforms, and clinical submission readiness.