Senior Manager, Pharmacometrics, Data Sciences

Role Overview

• Apply pharmacometric knowledge in quantitative pharmacology and sciences in non-clinical and clinical pharmacokinetic (PK) / pharmacodynamic (PD)
• Develop, execute and interpret pharmacometric analyses, including population PK and PK/PD models, Non-Compartmental Analysis (NCA), exposure-response modeling, clinical trial simulations.
• Develop and validate pharmacometric models to support dose selection, trial design, and decision-making.
• Analyze and interpret complex pharmacokinetic (PK) and pharmacodynamic (PD) data, integrating results with clinical and preclinical data.
• Author and review technical protocols, analysis plan, reports and scientific publications.
• Review regulatory documents in area of expertise.
• Propose innovative quantitative pharmacology approaches and optimize modeling processes.
• Collaborate with clinical pharmacology, biostatistics, regulatory, and clinical development teams to align pharmacometric strategies with program objectives.
• Communicate modeling results and their implications to cross-functional teams and senior management.
• Represent the company in meetings with academic institutions and industry forums as a pharmacometric subject matter expert.
• Oversee multiple pharmacometric projects, ensuring timely delivery of high-quality outputs.
• Ensure contact with the client, manage project oversight, quality, and budget control.
• Ensure compliance with regulatory guidelines and internal quality standards.

Requirements

• Pharm D or Ph.D. in Pharmaceutical Sciences or Biomedical Engineering, with specialization in pharmacometrics
• 3-5 years of experience in pharmacometrics within the pharmaceutical or biotechnology industry
• Demonstrated expertise in population PK/PD modeling, exposure-response analysis, and clinical trial simulations.
• Proficiency in pharmacometric software (essentially NONMEM and R, PKanalyx or Phoenix Winonlin)
• Knowledge of PKSim, Monolix, MATLAB is a plus.
• Strong analytical and problem-solving skills, with the ability to synthesize complex data into actionable insights
• Good written and verbal communication skills, with the ability to present complex concepts to diverse audiences.
• Organizational and project management skills, with the ability to manage multiple priorities.
• Knowledge of the pharmaceutical industry, including preclinical and early clinical development and the underlying pharmacometrics issues.

Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.