Senior Director, Clinical Pharmacology

Senior Director, Clinical Pharmacology at Syndax

Responsibilities include designing and interpreting diverse clinical pharmacology studies (FIH, bioavailability, food-effect, QT, DDI, organ impairment), applying model-informed drug development (MIDD) approaches, and supporting global regulatory submissions (INDs, CTAs, NDAs/BLA). The role also involves providing scientific leadership and mentorship within the clinical pharmacology team, engaging with health authorities, and influencing development decisions through quantitative analysis and modeling.

Requirements

PhD/PharmD in a relevant field, 15+ years industry experience, deep expertise in population PK/PD, exposure-response modeling, and experience with software such as NONMEM, R, Phoenix NLME. Extensive knowledge of FDA, EMA, GCP standards, and proven track record supporting regulatory submissions. Preferred: oncology drug development experience, particularly small-molecules, and familiarity with dose optimization.

Work setup

based in New York, NY, with details on compensation and benefits provided.