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Position: Manager – Invitro Biology
Location: Vadodara, Gujarat, India
Roles & Responsibilities:
This is a position for a highly motivated individual who will be primarily responsible for designing and perform pharmacokinetic data analysis of phase 1 clinical PK studies, FIH (SAD/MAD), DDI, AME, and special population studies for new molecular entities. The individual would be responsible to integrate pharmacokinetic and metabolism data across clinical studies and performing PK modeling and simulations to support informed decision-making on appropriate doses, dosage forms, and regimens teams.
- Design and provide synopsis/ study protocols for phase 2 clinical PK studies in collaboration with clinical, formulation, and regulatory teams.
- Analyze PK data from phase 1 clinical studies using an appropriate software like WinNonlin, NONMEM, SPLUS or SAS and prepare study reports for regulatory submissions.
- Development and application of PBPK or appropriate modeling tools for human PK and clinical DDI predictions
- Collaborate with clinical pharmacology in the modeling of emerging PK and PK?PD data and exposure-response analysis to aid in the selection of appropriate dose, dosage form, and regimen
- Responsible for authoring and/or reviewing relevant clinical pharmacology sections of the regulatory documents, such as IB, IND, labeling, and NDA.
- Sound knowledge of pharmacokinetic and pharmacodynamics principles and overall ADME of small and large molecules
- Strong modeling and simulation expertise in clinical PK and PK/PD.
- Working knowledge of pharmacokinetics and clinical pharmacology discipline and its method and approaches
- Must have hands-on experience with PK data analysis using data processing software such as Phoenix NLME, NONMEM, R, Gastro Plus, SimCYP, PUMAS, etc.
Qualification: M.Pharma, Ph.D
Experience: 8-13 Years
Mr. Kushal Paliwal
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