Description

You will lead the vision, strategy, and execution of analytical development and QC across a growing oncology portfolio, building and scaling a phase-appropriate organization that enables rapid development while positioning for late-stage and commercialization. As a key member of the PDM leadership team, you will shape analytical strategy at the enterprise level, ensuring robust control strategies, regulatory readiness, and operational excellence across internal and external networks.

Requirements

• PhD (preferred) or MSc in Analytical Chemistry, Pharmaceutical Sciences, or related field
• ~18+ years of industry experience with significant leadership in analytical development and QC
• Proven track record supporting late-stage development and global regulatory filings (IND/NDA/MAA/JNDA)
• Deep expertise in GMP, quality systems, and global regulatory expectations (FDA, EMA, ICH)
• Extensive experience managing external analytical networks (CDMOs, CTLs)

Responsibilities

• Define and drive enterprise-wide analytical development and QC strategy aligned with portfolio and corporate objectives
• Build, lead, and scale a high-performing ADQC organization to support multi-asset oncology pipeline
• Design and implement phase-appropriate analytical strategies including characterization, specification setting, and control strategies
• Oversee impurity profiling, degradant analysis, comparability, and lifecycle management of analytical methods
• Lead analytical strategy for global regulatory submissions (IND, IMPD, NDA, MAA, JNDA) and represent ADQC in health authority interactions