Senior Director, Clinical Pharmacology

November 19

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Immunovant

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 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.

🎯 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