Job Description
Conceive and execute novel scientific research or development in Clinical Pharmacology to achieve Clinical Pharmacology and Pharmacometrics (CPPM) goals. Generate new PK/PD proposals and lead those efforts. Investigate, identify, develop, and optimize new PK/PD methods and techniques. Act as a lead PK scientist; critically evaluate 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, investigator brochure sections, common technical documents, white papers, and similar materials.
- Conduct data analyses including non-compartmental analyses, modeling and simulation, and literature data analyses.
- Participate and present at departmental and cross-functional teams (study teams, clinical pharmacology/biopharmaceutics, clinical strategy, Clinical Pharmacology 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 with 0 years’ experience, or PharmD with 2+ years’ experience; Master’s degree (typically 8+ years); Bachelor’s degree (typically 10+ years). Relevant field includes PK, PBPK, PK-PD, pharmacometrics, systems pharmacology, drug metabolism/transporters.
- Excellent interpersonal skills; ability to interact externally/internally and work in teams.
- Scientific acumen and technical skills.
- Leadership competencies: persistent/resilient, learns from mistakes/failure, delivers results for long-term success, generates original ideas, and influences cross-functional alignment.