Conceive and execute novel scientific research or development in Clinical Pharmacology that achieves projects and Clinical Pharmacology and Pharmacometrics (CPPM) goals. Generate new PK/PD proposals and lead those efforts. Investigate, identify, develop, and optimize new methods and techniques in PK/PD field. Act as a lead PK scientist in his/her area of expertise and critically evaluate relevant Clinical Pharmacology, PK/PD and regulatory advances and integrate this knowledge into research or development programs.
Responsibilities
Contribute to clinical development by supporting Phase 1-4 studies including study design, and clinical pharmacology strategy.
- Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, relevant section of investigator brochures, common technical documents, white papers, and other similar documents.
- Conduct data analyses including non-compartmental analyses, modeling and simulation, literature data analyses.
- Participate and present at various departmental and cross functional teams such as study teams, clinical pharmacology and biopharmaceutics, clinical strategy team, Clinical Pharmacology leadership team, Journal club.
- Collaborate with scientific support from other Clinical Pharmacology functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
- Author scientific publications and present at scientific conferences.