Immunovant
Dedicated to enabling normal lives for people with autoimmune diseases
Senior Director, Clinical Pharmacology
Location
United States
Posted
117 days ago
Salary
$250K - $305K / year
Postgraduate Degree8 yrs expEnglish
Job Description
• 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 inquires, 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.
Job 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.
- Thrives in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment.
- Natural collaborator who enjoys working on a cross-functional team.
Benefits
- Medical, dental, and vision
- 401k
- Unlimited paid time off
- Parental leave
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