Senior Director, Clinical Pharmacology

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. The Senior Director, Clinical Pharmacology is responsible for developing clinical pharmacology plans and overseeing the execution of these plans across therapeutic areas and in all phases of clinical development.

Requirements

• 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 including nonclinical, clinical, CMC, regulatory, finance and legal.
• Knowledge of regulatory expectations for clinical pharmacology
• Excellent written and oral communication skills with meticulous attention to detail.

Benefits

• 401k
• Unlimited paid time off
• Parental leave
• Medical, dental, and vision