Associate Director, Analytical Strategy (m/w/x)

Associate Director, Analytical Strategy (m/f/x)

The Associate Director, Analytical Strategy will lead the development and execution of analytical strategies to support biopharmaceutical development programs. This role
requires deep molecular knowledge, expertise in analytical testing and molecule characterization, and a strong understanding of Quality by Design (QbD) principles and
regulatory requirements. The successful candidate will drive analytical decision-making, ensure robust characterization of molecules, and support regulatory submissions
with scientific rigor.

Main Responsibilities & Accountabilities

Strategic Leadership

• 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

Scientific Oversight

• 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

Regulatory & Compliance

• 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

Cross-Functional Collaboration

• 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

Leadership & Management

• Lead and mentor analytical scientists and project leaders
• Manage budgets, timelines, and resource allocation
• Build and scale analytical capabilities and infrastructure

Qualifications & Experience Requirements

• PhD in analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience)
• Typically 8+ 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