Scientific Project Leader
3 weeks ago
Job Title: Scientific Project Leader
Job Summary:
We are seeking a highly experienced Scientific Project Leader to lead clinical and non-clinical projects and scientific support on biopharmaceutical development for LBOE & Global projects at Ferring India FHPDC R&D.
Key Responsibilities:
- Plan, conduct, and manage early to late phase clinical development studies to achieve clinical studies for 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.
- Plan, conduct, and manage 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 achieve management & compliance as per requirements of Ferring/GxP/Regulatory.
- Scientific support to development team on new product ideation, biopharmaceutical strategy & evaluations; supporting for innovations to achieve NDDS development.
- Training of 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.
- Coordination for clinical & non-clinical study supplies Investigational medicinal product (IMP, NIMP, stationary, biological sample, etc.) to achieve IMP supply.
- Managing medical writing (protocol, ICD, CRF, etc.) from CROs/Ferring to achieve study documents at optimum quality.
- QA compliance for local Clinical and non-clinical studies to achieve quality compliance.
- Review of dossier/notifications for submission to IEC & Regulatory Authorities for clinical studies to achieve regulatory compliance.
- Supervising for safety reporting to Ferring GVP center and Regulatory Authority to achieve regulatory & GCP compliance.
- Review of scientific data (PK / PD and statistical data/results) to achieve high-quality data.
- Evaluation of clinical and non-clinical study Vendors & facilitating QA audit and selection of vendors to achieve qualified vendors.
- Support Ferring Global initiative for 'Collaborative Innovation' / Global creativity awards and support for identifying & evaluation of global/local collaborative organization to nurture innovation for building pipeline.
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