Associate Director, Quantitative Pharmacology

Role: Associate Director in Quantitative Pharmacology leading model-informed drug development strategies across modalities like antibodies, siRNA, and gene therapies. Objectives include supporting dose selection, trial design, and regulatory strategy from early development through submission. Responsibilities encompass leading PK/PD, exposure–response, and translational modeling, collaborating with Clinical Pharmacology, Biostatistics, and translational teams; representing QP in program meetings; authoring regulatory documents; mentoring junior scientists; and driving process and tool improvements. Requirements: PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or related field; 6+ years postdoctoral or industry experience (or MS with 9+ years); expertise in population PK/PD, exposure–response, or systems biology modeling using tools like NONMEM, Monolix, MATLAB, R; track record supporting regulatory submissions, with experience engaging with agencies like FDA and EMA; strong communication skills. HighValue: biopharma (antibodies, siRNA, gene therapies), early to post-IND stages, modeling and regulatory interface, cross-disciplinary collaboration, global regulatory interactions. Work setup: remote with 4 onsite days in NY, MA, or NJ; location flexibility. Travel not explicitly specified.