Sr. Manager For Bioequivalence & Biosimilar Clinical Study Operation

Hiring for Sr. Manager / AGM for Bioequivalence & Biosimilars Clinical Study Operation.

Qualification

• M.Pharm (Pharmacology/Pharmaceutics/Clinical Pharmacy or equivalent)

Experience

• 10 to 15 years of relevant experience in Clinical Research, Biosimilar Development, and Bioequivalence (BE) Studies in the pharmaceutical industry/CRO.
• Experience in managing biosimilar clinical development programs and regulatory studies is preferred.

Key Responsibilities

• Lead the planning, design, execution, monitoring, and reporting of Biosimilar and Bioequivalence (BE) studies.
• Provide scientific and operational expertise for biosimilar development programs, including PK/PD studies, comparative clinical pharmacology studies, confirmatory Phase III efficacy and safety studies, immunogenicity assessments, and other regulatory-required studies.
• Design and review clinical study protocols, informed consent documents, CRFs, and other study-related documents to ensure scientific and regulatory compliance.
• Participate actively in study design discussions, protocol development, feasibility assessments, and overall clinical development strategy.
• Coordinate with CROs, clinical sites, central laboratories, bioanalytical laboratories, and cross-functional teams to ensure timely and high-quality study execution.
• Review study documents, including study plans, monitoring reports, clinical study reports (CSRs), and bioequivalence study reports for scientific accuracy and regulatory compliance.

Required Skills:

• Comprehensive knowledge of biosimilar development pathways and regulatory requirements.
• Thorough knowledge of ICH-GCP, NDCTR, CDSCO, USFDA, EMA, and other global regulatory requirements applicable to biosimilars and BE studies.