Senior Director
4 days ago
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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