Pharmacokinetics Scientist

Core Responsibilities:

1. Design and Analyze PK Studies

o Plan clinical PK studies synopsis and feasibility

o Analyze PK data using modeling and simulation tools (e.g., Phoenix WinNonlin, R software).

o Interpret PK parameters such as C_max, AUC, T_max, half-life, clearance, and volume of distribution.

2. Support Drug Development

o Provide PK and statistical input in clinical development phase studies protocol

o Evaluate food effect, drug-drug interactions (DDIs), and bioavailability/bioequivalence studies and provide scientific inputs for study design & protocol preparation

o Support dose selection and optimization strategies for pivotal study design.

3. Regulatory Submissions

o 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

o Prepare and review PK-Statistical sections for regulatory documents (e.g., ANDA, IND, NDA, BLA, CTA).

o Respond to Health Authority questions related to pharmacokinetics.

4. Cross-functional Collaboration

o Work closely with clinical, bioanalytical, statistical and regulatory teams.

o Participate in multidisciplinary project teams to inform decision-making.

5. Data Interpretation & Reporting

o Summarize findings in study reports and scientific publications (as applicable).

o Present PK data to internal teams and external teams (Sponsor, DSMB and other regulatory bodies)

o Experience into study design, protocol writing, through knowledge of regulatory guidance for BA/BE studies as well as PK clinical trials.