Senior Biopharmaceutical Development Lead

3 weeks ago


Hyderabad, Telangana, India Ferring Pharmaceuticals Full time
Job Summary

We are seeking an experienced Senior Biopharmaceutical Development Lead to join our team at Ferring Pharmaceuticals in Hyderabad. As a key member of our development team, you will be responsible for leading clinical and non-clinical projects and providing scientific support on biopharmaceutical development for LBOE & Global projects.

Key Responsibilities
  • Develop and execute project plans for early to late phase clinical development studies to achieve proof of concept/registration of products in India & global markets.
  • Plan, conduct, and manage BA/BE studies in healthy volunteers to achieve proof of concept/registration of products in India & global markets.
  • Lead non-clinical studies (PK/PD, toxicity, etc.) to achieve non-clinical studies for proof of concept/regulatory requirements.
  • Manage study activities at CROs and Global Dept.'s to ensure management & compliance as per requirements of Ferring/GxP/Regulatory.
  • Provide scientific support to the development team on new product ideation, biopharmaceutical strategy & evaluations; supporting innovations to achieve NDDS development.
Requirements
  • M Pharma/M.S or Ph.D. (Pharmacology/Medicine) or equivalent from a reputed University.
  • At least 15 years of industrial experience in drug product development in early to late phase clinical development, BA-BE studies in healthy volunteers, PK-PD translation, and exposure to non-clinical studies.
  • Trained in Good Clinical Practices (GCP) and experience in clinical trial supply management (IMP, biological samples, etc.).
  • Thorough knowledge of regulatory & ethical requirements, Quality standards, PV, etc.
  • Experience in medical writing, biostatistics, Data Management, CTMS, vendor management, etc.
  • Experience of trial/study monitoring and handling GxP audit and regulatory inspections, etc.
About Us

Ferring Pharmaceuticals is a leading biopharmaceutical company with a strong presence in the Indian market. We offer a competitive salary package, including a base salary of ₹35 lakhs - ₹45 lakhs per annum, depending on experience, plus additional benefits.



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