Senior Director, Clinical Pharmacology

Role Summary

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. This leadership role will have direct reports and is an integral member of the project team, serving as the clinical pharmacology and pharmacometrics lead for individual asset(s). The role designs and interprets clinical pharmacology studies and writes relevant sections of regulatory documents, protocols, and study reports. It uses exploratory data analyses techniques, modeling, and simulations to accelerate development and support dosing, study designs, and development plans, and performs pharmacometrics analyses or provides scientific oversight of pharmacometrics analyses performed by external resources.

Responsibilities

• 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 as needed (IND, health authority inquiries, preparation/participation in meetings with health authorities, preparation of relevant BLA sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings)
• Support cross-functional teams, including Statistics, Data Management, Clinical, Preclinical/Nonclinical, Translational Science, as needed

Qualifications

• 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
• Thrives in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment
• Natural collaborator who enjoys working on a cross-functional team

Skills

• Clinical pharmacology study design and interpretation
• Pharmacometrics analytics and modeling
• Regulatory writing and communication
• Strong collaboration and cross-functional leadership
• Proficiency with pharmacokinetics/pharmacometrics software (e.g., NONMEM, WinNonlin)
• Data analysis, modeling, and simulation

Additional Requirements

• Domestic or international travel may be required (<10%)