- Clinical Trial Design: Develop study protocols, select proper dosing strategies, and define endpoints for Phase IIII clinical trials.
- PK/PD Analysis: Evaluate absorption, distribution, metabolism, and excretion (ADME) data using modeling and simulation software.
- Regulatory Compliance: Prepare safety profiles and data packages to support submissions to regulatory agencies like the US FDA or EMA.
- Cross-Functional Collaboration: Work with bio-statisticians, toxicologists, and clinical teams to interpret results and guide drug development milestones.
- Pharmacovigilance: Monitor adverse drug reactions and provide prescribing recommendations to medical professionals