Teams at Regeneron

As a Director in Quantitative Pharmacology, you oversee PK/PD evaluations, ensure high-quality analyses and reports, and communicate regulatory developments effectively. You need extensive experience in pharmacokinetics, author regulatory documents, and display excellent communication skills. A PhD and 10+ years in the field are required.

Lead model-informed drug development (MIDD) and pharmacometrics strategies across modalities; deliver population PK/PD, exposure-response, and translational modeling; inform dose selection, trial design, and regulatory strategy; represent QP in program meetings and regulatory interactions; author regulatory documents; mentor junior scientists; implement new modeling approaches and ensure scientific and regulatory quality.

Manage regional clinical study delivery in collaboration with Clinical Study Lead, CROs, and vendors. Oversee study documentation, systems (CTMS, TMF, EDC, IVRS/IWRS), vendor contracting, recruitment/retention, data quality, budgeting, timelines, and close-out activities while ensuring ICH/GCP and inspection readiness.