Director, Analytical Strategy

Develop and lead the global analytical strategy aligned with program and corporate goals. Provide scientific and regulatory guidance for analytical plans across all development phases (discovery → post-marketing). Drive innovation in analytical technologies, platforms, and workflows. Represent analytical function in cross-functional governance and decision-making forums. Oversee development, validation, and implementation of analytical methods (e.g., LC-MS/MS, ligand binding assays, biomarkers, immunogenicity). Ensure high-quality data generation for PK, PD, biomarker, and immunogenicity studies. Review and approve analytical study designs, reports, and regulatory documentation. Troubleshoot complex scientific and technical challenges. Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, GLP, GCP). Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA). Interface with regulatory agencies and respond to health authority queries. Maintain inspection readiness and quality standards. Partner with Clinical Pharmacology, DMPK, Toxicology, Biomarkers, and Clinical Operations. Support translational strategy and dose selection decisions. Manage external CROs, academic collaborators, and technology vendors. Lead and mentor analytical scientists and project leaders. Manage budgets, timelines, and resource allocation. Build and scale analytical capabilities and infrastructure.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

• PhD in analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience)

• Typically 12–15+ years in bioanalysis within biotech, pharma, or CRO environments

• Deep expertise in LC-MS/MS, ligand binding assays, biomarkers, and immunogenicity testing

• Strong knowledge of regulatory requirements and analytical validation standards

• Proven leadership and strategic program experience

• Experience supporting regulatory submissions and health authority interactions