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

The position of Associate Director, Analytical Strategy guides the creation and implementation of analytical approaches that underpin the company’s biopharmaceutical programs, ensuring that molecular insights translate into robust product development. Day‑to‑day duties involve shaping a worldwide analytical plan that aligns with both project and corporate objectives, offering scientific and regulatory counsel throughout discovery, clinical, and post‑marketing phases. The role supervises the design, validation, and rollout of methods such as LC‑MS/MS, ligand‑binding assays, biomarker panels, and immunogenicity tests, guaranteeing reliable data for pharmacokinetic, pharmacodynamic, and safety studies. It also safeguards adherence to FDA, EMA, ICH, GLP and GCP standards, prepares analytical sections of IND, NDA, BLA and related filings, and fields questions from health authorities. Collaboration spans clinical pharmacology, DMPK, toxicology, biomarkers and operations, while external CROs, academic partners and vendors are coordinated. Leadership responsibilities include mentoring scientists, overseeing budgets, timelines and resource distribution, and expanding analytical infrastructure. Candidates must hold a doctorate in analytical chemistry, pharmaceutical sciences, biochemistry or a comparable discipline, or a master’s degree coupled with extensive practical experience. At least eight years of bioanalysis work in biotech, pharma or CRO settings is required, together with deep proficiency in LC‑MS/MS, ligand‑binding platforms, biomarker and immunogenicity testing, and a solid grasp of validation and regulatory expectations. Demonstrated ability to lead strategic programs and interact with regulatory bodies is essential. Additional strengths include experience managing external partners, driving innovation in analytical technologies, and building scalable capabilities across a global team. The role offers the chance to influence high‑impact drug development decisions within a collaborative, science‑driven environment.