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Asso. Director BioClinical Studies & Nano Products

14.00 to 16.00 Years   Hyderabad   20 Nov, 2020
FERRING THERAPEUTICS
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSBU Head / CEO / Director
EmploymentTypeFull-time

Job Description

Job Title:Asso. Director BioClinical Studies & Nano Products

  • Planning, conduction and management of external studies (BA/BE studies in healthy subjects)
  • Planning, conduction and management of non-clinical studies (PK/PD, toxicity, etc.)
  • Managing study activities at CROs and Global Dept. s
  • Scientific support to NDDS development team on biopharmaceutical strategy & evaluations; supporting for innovations
  • Managing organoleptic studies at CRO
  • Training of project staff at Ferring and vendors (CROs)
  • Project Management 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]
  • Coordination for clinical & non-clinical study supplies Investigational medicinal product (IMP, NIMP, stationary, Biological sample, etc.)
  • Managing medical writing (protocol, ICD, CRF, etc.) from CROs/Ferring
  • QA compliance for local Clinical and non-clinical studies
  • Review of dossier/notifications for submission to IEC & Regulatory Authority and presenting in Regulatory committees (SEC, etc.) for clinical studies
  • Supervising for safety reporting to Ferring GVP center and Regulatory Authority
  • Review of scientific data (PK / PD and statistical data/ results)
  • Evaluation of clinical and non-clinical study Vendors & facilitating QA audit and selection of vendors
  • Managing/supporting future BA/BE studies for LCM (Global) in India
  • Support Ferring Global initiative for Collaborative Innovation / Global creativity awards and also support for identifying & evaluation of global/local collaborative organization
  • Supporting IPC-I for collaboration
  • Heading Nanotechnology lab and developing novel Nanotechnology /specialized drug delivery products
Required Education/Qualifications/Skills:Ph.D. (Pharmacology/Medicine); 10 to14 Years experience in Pharmaceutical R&D (Clinical & non-clinical studies) & Pharm. Dev.Location:Ferring India IPC R&D,

Keyskills :
project riskproject costdrug deliveryenvironmental toxicologyqa audit

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