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5.0 - 9.0 years
0 Lacs
ahmedabad, all india
On-site
Role Overview: As a Pharmacokinetic and Pharmacodynamic Modelling Scientist, you will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models to support drug development programs. You will work closely with cross-functional teams to guide decision-making and project direction. Additionally, you will be using advanced statistical approaches for bioequivalence analysis and large-scale data handling. Key Responsibilities: - Develop, validate, and apply pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling). - Conduct pharmacokinetic modelling and simulation analysis for project advancement. - Predict human pharmacokinetics based on diffe...
Posted 6 days ago
5.0 - 7.0 years
4 - 8 Lacs
ahmedabad
Work from Office
Study feasibility and planning inputs Provide inputs in PK/PD/IM based study porotocol and plans Operational expertise in use of Phoenix WinNonlin, NLME and IVIVC tools Regualtory query response and techincal consultation with study team Scientific support in pre-clinical, clinical and in-vitro study planning & execution PK/Stats data analysis and reveiw of study reports EXPERIENCE Pharma industry / CRO experience with > 5 yrs - core invlovement in PK/PD/IM - BABE study planning & data analysis Involved in regualtory query resposness, investigaiton and reporing EDUCATIONAL QUALIFICATION M.Pharma (Pharmacology) or Pharm.D. (Pharmacology) or Ph.D. (Pharmacology)
Posted 3 months ago
5.0 - 10.0 years
6 - 8 Lacs
hyderabad, gaddapotharam
Work from Office
a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must. Excellent knowledge on product development and clinical studies
Posted 3 months ago
5.0 - 9.0 years
0 Lacs
ahmedabad, gujarat
On-site
You will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) to support drug development programs. This includes conducting and presenting pharmacokinetic modelling and simulation (M&S) analysis to management and technical teams for project advancement. You will also predict human pharmacokinetics based on in-silico, in-vitro, and in-vivo data, including dose scaling and profile prediction. Additionally, you will conduct IVIVE and IVIVC and work closely with cross-functional teams, including preclinical, clinical, and regulatory teams, to guide decision-making and project direction. Utilizing software tools such as Win...
Posted 3 months ago
5.0 - 10.0 years
9 - 17 Lacs
Hyderabad
Work from Office
Job Responsibilities : Develop and validate IVIVC and PBPK models to predict in vivo drug performance from in vitro data. Conduct in vitro experiments such as solubility, dissolution, and permeability studies using biorelevant media. Collaborate with formulation, analytical, and clinical teams to optimize drug product development. Analyze bioequivalence (BE) study data and support regulatory submissions with modeling insights. Prepare and review technical reports, protocols, and regulatory documentation . Preferred candidate profile & Qualifications: Should be well versed with IVIVC concepts,preferably 5-10 years of experience. Should have excellent knowledge on product development and clini...
Posted 6 months ago
6 - 10 years
0 - 0 Lacs
Hyderabad
Work from Office
a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must.
Posted 7 months ago
5 - 10 years
6 - 8 Lacs
Hyderabad, Gaddapotharam
Work from Office
a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must. Excellent knowledge on product development and clinical studies
Posted 7 months ago
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