Senior Director

4 days ago


Hyderabad, Telangana, India Ferring Pharmaceuticals Full time

Job Title: Senior Director - Biopharmaceutical Development

Job Summary:

We are seeking a highly experienced Senior Director to lead our biopharmaceutical development team. The successful candidate will have a strong background in clinical and non-clinical studies, with a proven track record of delivering projects on time and within budget.

Key Responsibilities:

  • Lead clinical and non-clinical projects, including synopsis development, planning, conducting, and management of early to late phase clinical development studies.
  • Manage study activities at CROs and Global Dept.'s to achieve management and compliance as per requirements of Ferring/GxP/Regulatory.
  • Provide scientific support to development teams on new product ideation, biopharmaceutical strategy, and evaluations.
  • Train project staff at Ferring and vendors (CROs) to achieve training for GxP compliance.
  • Project Management - Clinical development, BA/BE & Non-clinical [Project presentations to Ferring committees; Project risk assessment and scientific assessments with KOLs and mitigation; project cost and resource planning and management] to achieve project milestones.

Requirements:

  • At least 15 years of industrial experience in drug product development in early to late phase clinical development.
  • Hands-on experience in BA-BE studies in healthy volunteers.
  • Hands-on experience in PK-PD translation.
  • Exposure to non-clinical studies will be an added advantage.
  • Qualification: M. Pharma/M.S or Ph.D. (Pharmacology/Medicine) or equivalent from a reputed University.


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