Associate Director - Immunoassay

Overview

Associate Director leading immunoassay and broader bioanalytical/biomarker strategy for regulated clinical trial deliverables. Accountable for timely, compliant PK, immunogenicity, and biomarker data across global development programs.

What you'll do

• Lead bioanalytical strategy and contribute to biomarker strategy for multiple global clinical development programs.
• Independently design and execute bioanalytical/biomarker deliverables as the SME, ensuring alignment with global guidance and applicable India regulatory requirements.
• Provide scientific and technical oversight of bioanalytical vendors for method development, validation, lifecycle management, and clinical sample testing.
• Partner with Quality for vendor qualification, audit readiness, and adherence to GxP and applicable regulations.
• Provide SME support for data analysis and regulatory submissions, including drafting responses to health authority questions.
• Review PK, immunogenicity, and biomarker results and relevant sections of CSR and submission documents.
• Coordinate a matrix team to plan and execute deliverables and proactively manage/escalate critical risks and decisions.

What you'll need

• PhD with 10+ years of experience, or MS with 16+ years, or BS with 18+ years (including 7+ years of industry experience).
• In-depth expertise in bioanalytical chemistry, immunology, and bioanalytical techniques in drug development context.
• Expertise in one or more biomarker technologies including immunoassays.
• Knowledge of global and India-specific regulatory guidance for method validation and clinical/preclinical sample testing.
• Experience overseeing India-based and global laboratories/CROs, including vendor governance and CAPA follow-up.
• Strong technical knowledge across drug development allied fields (e.g., drug metabolism, pharmacology, toxicology).
• Excellent oral and written communication skills for scientific documents.

Nice to have

• Polish language proficiency is preferred.

Details

• Location: Bengaluru, India (Research and Development).
• Employment: Full time (Regular), Employee worker type.