Senior Biopharmaceutical Development Lead
3 weeks ago
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.
- 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.
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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