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| Job Location | North Delhi, Delhi |
| Education | Not Mentioned |
| Salary | 12,00,000 To 15,00,000 p.a. |
| Industry | Pharma/BioTech/Clinical Research |
| Functional Area | Pharma / R&D / Biotech |
| EmploymentType | Full-time |
Responsible for planning, conducting, and reporting the study to DRA, maintaining the integrity of preclinical data, and for ensuring that project timelines are met. Sound knowledge of Preclinical Pharmacokinetics and Pharmacodynamics, responsible for the design, pharmacokinetic analysis, and reporting of non-clinical animal pharmacokinetic, toxicokinetic, and ADME studies. Responsible for the oversight of external pharmacokinetic studies, establish deliverables, maintain timelines, and foster open communication with and between the Project Teams, Preclinical Operations, Pharmacometrics, Toxicology and Functional Heads. Responsibilities will also include reviewing and providing content and subject matter expertise relating to preclinical pharmacokinetics, toxicokinetics, efficacy and ADME sections of regulatory documents to include: INDs, BLAs and other regulatory submissions and responses, as needed. Experience with PK software and have an understanding of non-compartment & multi-compartment modeling Effectively manage the preclinical PK team tasked with study design, protocol development and study execution of GLP and non-GLP pharmacokinetic, toxicokinetic, and ADME (as needed) studies, with competing and aggressive time lines, prioritizing activities, and working independently. Supervise, assist, and mentor contributing scientists on pharmacokinetic, efficacy analysis, data interpretation, and report writing. Empower subordinates and provide for the professional development of their staff. Functions as study director or principal investigator responsible for externally conducted PK, and ADME (as needed) studies as appropriate. Interact with the Scientific Writing Team in the creation of preclinical PK/TK written and tabulated summaries for IND and BLA applications, as well as IBs, annual updates and other regulatory activities. Interact closely with other managers and contributing scientists tasked with bioanalytical assay develop.
Keyskills :
Pharmacy