Clinical Pharmacokinetics Scientist

Aizant Drug Research Solutions is hiring Clinical Pharmacokinetics Scientist for our Bioavailability (BA) and Bioequivalence (BE) studies. We are looking for highly skilled and experienced professionals to join our clinical research team.

Location: Dulapally, Hyderabad

Requirements: M.Pharm or Ph.D with a minimum of 4 years of relevant working experience mandatory.

Responsibilities:

• Good understanding of Pharmacokinetics
• Designing of BA-BE studies for generics and complex generics including oral solids
• Good overall understanding of BA-BE guidelines for US, Europe, ANVISA,Malaysia, EMIN markets etc
• Able to review the clinical BA/BE protocols and provide inputs on the design like sample size, Blood collection time points, study design like parallel/cross over etc
• Basic understanding of Biopharmaceutics and PK Modeling
• Able to PK Trend analysis of pilot BE studies
• Perform in depth analysis of Pilot PK studies and basis this design the pivotal studies
• Suggest the team to optimally design the pivotal study basis pilot study outcome
• Perform root cause analysis of pilot and pivotal BE studies
• Work closely with medical writing and PK/stats team in preparation/review of protocol, CSR finalization
• Perform feasibility assessment based on Pharmacokinetics of the generic molecule and literature review
• Understand and review available Biopharmaceutics and clinical pharmacology reviews and determine the study design
• Good hands on experience on Phoenix WinNonlin, Gastroplus other PK software's

To Apply - Share resume to aishwaryarani.k@aizant.com