Zydus Cadila
Location
Ahmedabad | India
Job description
1. Clinical and preclinical development of 505(b)(2) products:
a. Literaturesearch focusing preclinical and clinical development programme
b. Understandingand defining the rationale of unmet need for identified product
c. Thoroughunderstanding of disease physiology, preclinical safety pharmacology.
d. Identifyingappropriate CRO for conducting non-clinical POC, Toxicity, safety pharmacologystudies, PK/PD studies in human, bioequivalence/bioavailability studies.
e. Budgetingof preclinical and clinical studies
f. Authoringand review of study plan, protocol, scientific justification, publication fornon-clinical studies.
g. Review thedata of preclinical POC, bioavailability and bioequivalence studies and leadingthe discussion with different cross functional team and CRO.
h. Authoringand review of clinical, non-clinical sections in IND, briefing package,Investigators Brochure and NDA for regulatory submission.
i. Monitoringof preclinical and clinical studies in India and overseas CROs
j. Overseelocal regulatory application submission and approvals.
2. Genotoxicity/Toxicity studies:
a. Outsourcingand overseeing all technical and regulatory aspects of AMES test (Invitro,Invivo tissue distribution studies) and toxicity studies.
b. Review ofstudy data, study report and defining the strategy for the assessment ofgenotoxicity/toxicity study as per USFDA, ICH, OECD guidance.
c. Managingthe budget and financial aspects of CROs.
Job tags
Salary
