About The Position
The Analytical Strategy Director is a senior scientific and strategic leadership role responsible for designing and overseeing analytical strategies that support drug discovery, development, and regulatory approval. This position ensures robust, compliant, and innovative analytical approaches across preclinical, clinical programs and LCM.
Requirements
- 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
Responsibilities
- 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
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
