Senior Director, Clinical Pharmacology

PhD, PharmD, or MD with training in CP, PK/PD, Pharmacology, and Pharmaceutical Sciences 8-10 years of experience in the application of CP within the context of drug development in the healthcare industry Experience in leadership of CP regulatory submission and approvals of at least one original or major NDA/CTDs or multiple supplemental NDA/CTDs (global or regional) Proven track record of clinical pharmacology and pharmacokinetic / pharmacometrics support for regulatory submissions (e.g., EoP2, IND, NDA, MAA, PIP) Experience and expertise with pharmacokinetics / pharmacometrics methods and software (e.g, NONMEM, WinNonlin) Deep understanding of drug development and the integration across the various functions Knowledge of regulatory expectations for clinical pharmacology Excellent written and oral communication skills with meticulous attention to detail

Serve as the head of clinical pharmacology and leader of the function for all indications Develop clinical pharmacology strategy for all Immunovant compounds and design, interpret, and conduct clinical pharmacology studies Provide clinical pharmacology support for Ph 1, 2, and 3 studies Support clinical pharmacology aspects of regulatory submissions including writing and review of relevant sections Provide data analyses, modeling and simulation to support asset development; perform pharmacometrics analyses or provide scientific oversight of pharmacometrics analyses performed by external resources Collaborate closely with Regulatory to provide CP support of regulatory documents, communications, and presentations Support cross-functional teams, including Statistics, Data Management, Clinical, Preclinical/Nonclinical, Translational Science, as needed