Binay Thakur

About Binay Thakur

I am a seasoned clinical research professional with 19 years of diverse experience across Sponsor and CRO environments. My expertise spans end-to-end management of Phase I–IV trials for NCEs, NBEs, generics, and biosimilars, supporting regulatory submissions to USFDA, EMA, and PMDA. I currently lead the execution of global biosimilar studies, ensuring regulatory compliance and strategic delivery. With a strong grasp of international clinical operations, I effectively manage CRO partnerships and coordinate with cross-functional internal stakeholders to drive successful outcomes.

Experience

1. Director

   Biocon Biologics

   Oct 2025 — Present · IN

Education

• Central Hindu Boys School

  10+2, Science

• Utkal University

  M.Sc, Biotechnology

  2002 — 2004

• Kendriya Vidyalaya Karo Special Bokaro

  10th

• Jawaharlal Nehru Vishvavidyalaya

  Advanced PG Diploma in Bioinformatics, Bioinformatics

  2004 — 2005

• Maharshi Dayanand Sarswati University

  B.Sc.B.Ed., BioSciences

  1998 — 2002

Skills

• Gcp
• Working Knowledge of Gcp
• Cardiology
• Clinical Operations
• Edc
• Therapeutic Areas
• Good Clinical Practice (Gcp)
• Clinical Monitoring
• Regulatory Submissions
• CRO Management
• Conducting Monitoring & Co-Monitorings
• Vaccines
• Sop
• Inform
• Electronic Data Capture (Edc)
• Regulatory Affairs
• Lifesciences
• Infectious Diseases
• Life Sciences
• Clinical Research
• Clinical Development
• Oncology
• Protocol
• Clinical Trials
• Diabetes
• Writing Sops
• Trial Management
• Ich-Gcp
• Patient Recruitment
• Developing Project Progress Tracking Tools
• CRO
• Standard Operating Procedure (Sop)