Director, Quantitative Pharmacology and Pharmacometrics – Oncology

Role: Director of Quantitative Pharmacology and Pharmacometrics (Immune/Oncology) within the Global Clinical Development organization, focusing on drug development strategies for oncology therapeutics from post-PCC to registration. Responsibilities: serve as expert on Oncology development teams, develop and execute model-based analyses (PK/PD, exposure-response, disease progression, QSP, tumor size/survival modeling), strategize modeling approaches, and maintain regulatory understanding for small molecules and biologics in Oncology. Also involves authoring regulatory documents (INDs, CSRs, CTDs) and mentoring junior staff. Qualifications: Ph.D. with 7+ years or Master/PharmD with 9+ years in pharmaceutical drug development relating to PK/PD, pharmacometrics, or biomedical engineering; proven impact with pharmacometric methods; experience with IND/NDA submissions; proficiency in R, NONMEM, MATLAB, Monolix. HighValue: Oncology focus, biologics and small molecules, clinical pharmacology, model-based drug development, regulatory interactions, and post-PCC to registration stage. Collaboration: works closely with cross-functional scientists, external vendors, and partners, representing QP2-IO on development teams. WorkSetup: remote position eligible for non-commutable candidates; hybrid if within commuting distance; travel ~10%.