Associate Director – Bio-Clinical Studies
3 months ago
Job Description:
Role: Associate Director – Bio-clinical studies
Reporting to: Senior Director - Pharmaceutical Development
Location: Hyderabad
Experience: At least 15 years of industrial experience in the following:
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.
Purpose of the Role:
Leading Clinical and non-clinical projects and scientific support on Biopharmaceutical development for LBOE & Global projects
Job Description
Synopsis development, planning, conducting, and management of early to late phase clinical development studies to achieve Clinical studies for proof of concept /registration of product in India & global markets.
Planning, conducting and management of BA/BE studies in healthy volunteers to achieve Proof of concept /registration of products in India & global markets.
Planning, conducting, and management of non-clinical studies (PK/PD, toxicity, etc.) to achieve non-clinical studies for Proof of concept /regulatory requirements
Managing 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.
Required Competencies
Trained in Good Clinical Practices (GCP)
>10 years of experience in Clinical Trials and BA/BE studies management in capacity as Clinical Trial Project Manager
Experience in clinical trial supply management (IMP, biological samples, etc.)
Thorough knowledge of regulatory & ethical requirements, Quality standards, PV, etc.
Skills in Biopharmaceuticals related to NDDS development.
Knowledge & Experience of non-clinical studies for Pharmacokinetics and toxicity studies
Experience in medical writing, biostatistics, Data Management, CTMS, vendor management, etc.
Experience of trial/study monitoring and handling GxP audit and regulatory inspections, etc.
Location:
Ferring India FHPDC R&D-
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