Responsibilities

As the Senior Director, the individual will serve as the clinical pharmacologist for the company, providing strategic and scientific input across all clinical programs, leading the Clinical Pharmacology team accountable for the clinical pharmacology strategy, integrating clinical pharmacology knowledge with related disciplines, ensuring appropriate PK, PD, and PK/PD data analyses, collaborating with toxicologists and preclinical pharmacology scientists, ensuring adherence to timelines and budgets, developing and implementing new clinical pharmacology approaches, contributing to program strategy and study design, working closely with research and development teams, representing nonclinical and clinical pharmacology during meetings with regulatory authorities, and reviewing literature and publications to stay informed on regulatory developments. They will also create or guide summary documents and contribute to diligence assessments.