Manager – DMPK (PKPD) | Sun Pharma Advances Research | Vadodara

Job Description

Roles and Responsibilities:

• Extensive and in-depth knowledge of pharmacokinetics, drug metabolism, and PK/PD evaluation.
• Provide PK/PD model-based inputs on a dose, dose regimen & sampling time points for preclinical pharmacokinetic and PK/PD studies required to support robust preclinical data packages in collaboration with pharmacology and biomarker teams
• Perform PK and PK/PD analyses using data analysis tools such as Phoenix WinNonlin, Gastroplus, ADAPT5, etc.
• Perform Emax and Indirect response PK/PD modeling and simulation using Phoenix WinNonlin software
• Perform PBPK modeling and simulation to predict human pharmacokinetics and DDI potential using Gastroplus
• Perform mechanistic/system biological PK/PD modeling and simulations
• Predicting human dose and regimen together with providing input into exposure-response (biomarker) based decision criteria for early clinical trials.
• Perform quantitative and mechanistic PK/PD modeling and simulations to estimate MED, FIH, and RP2D dose range
• Present PK and PK/PD findings and represent the Pre-clinical Pharmacometrics group in cross-functional study team settings.
• Experience in working in project teams as well as sound awareness of recent developments in drug discovery and development
• Must be willing to work in a group of matrix structure without hierarchy as well as an individual contributor under supervision

Minimum Requirements:

• Ph.D. or an MS degree with proven industry experience in a discipline with a significant component of Modeling & Simulation, such as systems biology, quantitative pharmacology, or pharmacometrics.
• Relevant industry experience in Modeling & Simulation, ideally in preclinical/translational settings with a focus on small and large molecules
• Specialist in tools such as WinNonLin/Phoenix and Gastroplus®.
• Excellent interpersonal and communication skills

Qualification: M.Pharma, Ph.D.