Senior Manager, Pharmacometrics, Data Sciences

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Utilize pharmacometric expertise in quantitative pharmacology and sciences for both non-clinical and clinical pharmacokinetic (PK) and pharmacodynamic (PD) applications.

• Design, implement, and analyze pharmacometric evaluations, which include population PK and PK/PD models, Non-Compartmental Analysis (NCA), exposure-response modeling, and clinical trial simulations.

• Create and validate pharmacometric models that assist in dose selection, trial design, and informed decision-making.

• Examine and interpret intricate pharmacokinetic (PK) and pharmacodynamic (PD) data, integrating findings with clinical and preclinical information.

• Draft and review technical protocols, analysis plans, reports, and scientific publications.

• Assess regulatory documents within the area of expertise.

• Suggest innovative quantitative pharmacology methodologies and enhance modeling processes.

• Collaborate with teams in clinical pharmacology, biostatistics, regulatory affairs, and clinical development to ensure pharmacometric strategies align with program goals.

• Effectively communicate modeling outcomes and their implications to cross-functional teams and senior management.

• Represent the organization in discussions with academic institutions and industry forums as a pharmacometric subject matter expert.

• Manage multiple pharmacometric projects, guaranteeing timely delivery of high-quality results.

• Maintain client contact, oversee project management, quality assurance, and budget control.

• Ensure adherence to regulatory guidelines and internal quality standards.

⛳️ Requirements

• Pharm D or Ph.D. in Pharmaceutical Sciences or Biomedical Engineering, specializing in pharmacometrics.

• 3-5 years of experience in pharmacometrics within the pharmaceutical or biotechnology sector.

• Proven expertise in population PK/PD modeling, exposure-response analysis, and clinical trial simulations.

• Proficient in pharmacometric software, particularly NONMEM and R, PKanalyx, or Phoenix Winonlin.

• Familiarity with PKSim, Monolix, and MATLAB is advantageous.

• Strong analytical and problem-solving abilities, with a knack for transforming complex data into actionable insights.

• Excellent written and verbal communication skills, capable of conveying complex concepts to varied audiences.

• Solid organizational and project management skills, with the capacity to juggle multiple priorities.

• Understanding of the pharmaceutical industry, including preclinical and early clinical development and the associated pharmacometric challenges.

🏝️ Benefits

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