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. Act as a lead PK scientist and critically evaluate relevant Clinical Pharmacology, PK/PD, and regulatory advances to integrate into research or development programs.
Responsibilities:
- Contribute to clinical development by supporting Phase 1β4 studies, including study design and clinical pharmacology strategy.
- Author regulatory documents (protocols, study reports, population PK, exposure-response analyses, investigator brochure sections, common technical documents, white papers).
- Conduct data analyses (non-compartmental analyses, modeling and simulation, literature data analyses).
- Participate and present in departmental and cross-functional teams (study teams, clinical pharmacology/biopharmaceutics, clinical strategy, CPPM leadership, journal club).
- Collaborate with 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.
Qualifications:
- PhD (0 years) or PharmD (2+ years); Masterβs (typically 8+ years); Bachelorβs (typically 10+ years). Relevant field: PK, PBPK, PK-PD, Pharmacometrics/system pharmacology, drug metabolism/transporters.
- Excellent interpersonal skills; ability to interact externally/internally and work in teams.
- Demonstrates scientific acumen and technical skills.
- Leadership competencies: persistent/resilient; learns from mistakes/failure; delivers business results; connects unrelated concepts; influences cross-functional alignment.