Posted:1 month ago|
Platform:
Work from Office
Full Time
Role & responsibilities Core Responsibilities: Design and Analyze PK Studies Plan clinical PK studies synopsis and feasibility Analyze PK data using modeling and simulation tools (e.g., Phoenix WinNonlin, R software). Interpret PK parameters such as C_max, AUC, T_max, half-life, clearance, and volume of distribution. Support Drug Development Provide PK and statistical input in clinical development phase studies protocol Evaluate food effect, drug-drug interactions (DDIs), and bioavailability/bioequivalence studies and provide scientific inputs for study design & protocol preparation Support dose selection and optimization strategies for pivotal study design Regulatory Submissions Deep understanding and knowledge of regulatory guidance (like US FDA, MHRA, EMA, HEALTH CANADA, ANVISA etc) documents pertain to BABE as well as clinical trials Prepare and review PK-Statistical sections for regulatory documents (e.g., ANDA, IND, NDA, BLA, CTA). Respond to Health Authority questions related to pharmacokinetics. Cross-functional Collaboration Work closely with clinical, bioanalytical, statistical and regulatory teams. Participate in multidisciplinary project teams to inform decision-making. Data Interpretation & Reporting Summarize findings in study reports and scientific publications (as applicable). Present PK data to internal teams and external teams (Sponsor, DSMB and other regulatory bodies)
Veeda CR
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