Assistant Manager - Biostatistics & Programming, PK Lambda Therapeutic Research

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 1 month ago

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Sr. Executive / Asst. Manager Tiefenbacher Group

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

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Deputy Manager - Pharmacokinetic Modelling and Simulation Scientist Amneal Pharmaceuticals

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...

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Senior Executive / Assistant Manager - IVIVC AET Laboratories

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 4 months ago

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IVIVC Scientist- Assistant Manager / Sr.Executive AET Laboratories

6 - 10 years

0 - 0 Lacs

Hyderabad

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Sr. Executive / Asst. Manager Tiefenbacher Group

5 - 10 years

6 - 8 Lacs

Hyderabad, Gaddapotharam

Work from Office

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