Associate Director Clinical Assay Strategy, Hematology And Cardiovascular & Renal X2

CSL Ltd

Waltham, MA, United States
**
Bioanalytical assay design and validation
Biomarker assay regulatory compliance
External vendor management and oversight
** CSL Ltd is seeking an Associate Director of Clinical Assay Strategy in Waltham, MA, to lead and manage bioanalytical and biomarker assays in support of clinical studies. The ideal candidate will have extensive experience in clinical biomarker assays and a solid background in regulatory standards, with a focus on collaboration and innovation in a hybrid work environment. **

Job Summary

  • This role leads the external tactical execution of bioanalytical and biomarker assays to deliver innovative data sets for nonclinical and clinical studies.
  • The position requires a deep understanding of regulatory standards across different platforms and assay types to ensure submission readiness.
  • CSL offers a hybrid work model with three days onsite at the Waltham MA office, fostering collaboration within an agile R&D team.

Matching Summary

Match Score: 75

** CSL Ltd is seeking an Associate Director of Clinical Assay Strategy in Waltham, MA, to lead and manage bioanalytical and biomarker assays in support of clinical studies. The ideal candidate will have extensive experience in clinical biomarker assays and a solid background in regulatory standards, with a focus on collaboration and innovation in a hybrid work environment. **

Skills & Requirements

Must-have

  • Bioanalytical assay design and validation
  • Biomarker assay regulatory compliance
  • External vendor management and oversight
  • PK ADA and biomarker assay expertise
  • Clinical study support and data delivery
  • Cross-functional team leadership

Nice-to-have

  • Experience in Hematology or Cardiovascular fields
  • Knowledge of AI in regulated environments
  • Strong scientific communication skills
  • Innovation in automated workflows
  • International multicultural team management

Key Requirements

  • Postgraduate degree (preferably PhD)
  • 8+ years relevant industry experience
  • Expertise in Hematology/CVR/Transplant/Immunology
  • Advanced education in Life Sciences discipline

Work Rights

Not specified

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