Senior Manager, Pharmacometrics and Data Sciences

• Development, execution and interpretation of 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

• Pharm D or Ph.D. in Pharmaceutical Sciences or Biomedical Engineering, with specialization in pharmacometrics
• A Master’s degree with substantial relevant experience will also be considered
• 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)
• Strong analytical and problem-solving skills
• Good written and verbal communication skills
• Organizational and project management skills
• Knowledge of the pharmaceutical industry, including preclinical and early clinical development and the underlying pharmacometrics issues
• Minimum knowledge of basic of IT
• Autonomous, concentrated and high-quality work
• Ability to work in team and manage more junior people in the context of an international team working remotely
• Sense of responsibility
• Knowledge of English

Knowledge of PKSim, Monolix, MATLAB is a plus

• medical
• dental
• vision care
• comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
• support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave
• variety of training programs
• professional development resources
• opportunities to participate in mentorship programs, employee resource groups, volunteer activities