Job Summary (Primary Function)
- Associate Director responsible for executing the pharmacometrics strategy and model-based analyses for clinical drug development. Develop and implement model-informed drug development (MIDD) strategies to optimize decision-making across all phases of drug development.
Key Responsibilities
- Independently conduct and report model-based analyses: population PK and PK/PD, exposure-response modeling, model-based meta-analyses (MBMA), disease progression modeling, and clinical trial simulation.
- Identify opportunities where modeling and simulation advance understanding of PK, PD, efficacy, and safety across multiple projects.
- Develop MIDD strategies across programs and disease areas to optimize prospective studies and inform clinical development and regulatory strategies (with clinical pharmacology, biostatistics, regulatory, and clinical development teams).
- Communicate results, conclusions, and assumptions to influence decision-making (written and oral).
- Mentor peers on pharmacometrics methodologies, tools, and application in clinical drug development.
- Stay current with scientific advancements and regulatory trends in clinical pharmacology and pharmacometrics; apply knowledge to advance drug development.
- Publish in peer-reviewed journals.
Qualifications
- Ph.D. in Pharmacometrics, Clinical Pharmacology, Applied Mathematics, Statistics, Engineering, or related field.
- 3β5 years of related industry experience.
- Hands-on experience with statistical programming and pharmacometrics tools, including R and NONMEM (or equivalents).
- Excellent communication skills; ability to collaborate cross-functionally.
- Strong time management; ability to balance multiple tasks to meet program goals.