ResponsibilitiesLead DMPK and PK/PD strategy across discovery and development programs, from candidate nomination through clinical development and regulatory submission Drive clinical pharmacology strategy including dose finding, exposure–response modeling, PK/PD analysis, and risk-benefit assessment for early- and late-stage programs Oversee PK/PD study design, analysis, and interpretation, collaborating with clinical operations, biostatistics, and regulatory colleagues Provide scientific and regulatory support for DMPK, Clinical Pharmacology, and Biopharmaceutics sections of regulatory submissions, including IND, NDA, and BLA filings Act as the subject‑matter expert for clinical pharmacology and DMPK in interactions with FDA, EMA, and other global health authorities Partner with translational, discovery, and clinical teams to integrate nonclinical ADME data into clinical development plans and support compound progression from pipeline to early development Work closely with Discovery and DMPK groups to provide PK/ADME support for discovery projects, enabling informed compound selection and optimization Ensure alignment of DMPK and PK/PD activities with clinical development, drug manufacturing, and regulatory plans across the portfolio Provide strategic and technical leadership to the AQP function on scientific matters, combining full‑time and consulting resources Plan and conduct stage‑appropriate Clinical Pharmacology studies (Phase I/II/III) to support regulatory submissio
