Job Description

:Role: Senior Research Associate/ Assistant Scientist - Bio- Clinical StudiesReporting to: Associate Director - Bio-Clinical StudiesLocation: HyderabadExperience: At least 7 years of industrial experience in the field of Bio-Clinical Studies with M. Pharma or 4 years of industrial experience with Ph.D.Qualification: M. Pharma/ M.S or Ph.D. (Pharmacology/Medicine) or equivalent from a reputed University.Purpose of the Role: Supporting and guiding projects through proof of concept to clinical development for LBOE & Global projectsKey Deliverables:Support Synopsis development, planning, execution 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.Support Planning, execution and management of BA/BE studies in healthy volunteers to achieve Proof of concept /registration of products in India & global marketsManage study activities at CROs and Global Dept.'s to achieve Management & compliance as per requirements of Ferring/GxP/ RegulatoryCoordinate for non-clinical and clinical study supplies Investigational medicinal product (IMP, NIMP, Biological samples, etc.) to achieve IMP supplySupport QA compliance for non-clinical GLP studies to achieve Quality compliancePerform and Support Review of dossier for submission to Regulatory Authority to achieve Regulatory compliancePerform and Support review of Bioanalytical method development & validation reports to achieve High Quality dataPerform and Support review of scientific data (PK / PD and statistical data/ results) to achieve High Quality dataPerform and Support evaluation of clinical and non-clinical study Vendors & facilitating QA audit and selection of vendors to achieve Qualified vendors.Preferred Competencies for success in the role:Hands on experience in BA-BE studies.Experience in drug product development in early to late phase clinical developmentHands on experience in PK-PD translationExposure to non-clinical studies will be an added advantage.Trained in Good Clinical Practices (GCP)5 years of experience in Clinical Trials and BA/BE studies managementExperience 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.Location: Ferring India FHPDC R&D

Ferring