Team Member – Population Pharmacokinetics (BiopharmPK)

About the role

We are looking for a Team Member to join our BiopharmPK group and lead population pharmacokinetics (POPPK) activities across multiple projects. The role supports data management, model development, simulation, and regulatory deliverables while building the team’s capability for future challenges.

Key responsibilities

• Manage and curate data required for POPPK analyses.
• Develop and validate population PK/PD and exposure‑response models to support study design and biowaivers within a Model‑Informed Drug Development framework.
• Run clinical trial simulations for dose‑response, special populations, and alternative dosing regimens.
• Prepare POPPK sections for NDA/ANDA/505(b)(2) submissions and respond to regulatory queries.
• Coordinate cross‑functional teams, organize meetings, and handle vendor logistics.
• Maintain modeling software, build automated workflows, and ensure quality control, traceability and compliance.

Required profile

• M.S., M.Pharm or PhD in Pharmaceutics, Pharmacology, Clinical Pharmacy or related field.
• 4–8 years of hands‑on experience in population PK/PD model development and validation.
• Proven ability to lead technical work and manage cross‑functional teams.

Required skills

• Proficiency with POPPK/PD software (preferably PUMAS).
• Population PK/PD modeling and exposure‑response analysis.
• Clinical trial simulation expertise.
• Regulatory report preparation for clinical pharmacology sections.
• Data management and automated workflow development.
• Quality control, traceability and compliance practices.