Apply on Employer Site

Immunovant · 20 hours ago

Senior Director, Clinical Pharmacology

United States

Full-time

Remote

Director/Executive

$250K/yr - $305K/yr

8+ years exp

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 their execution across therapeutic areas, leading the clinical pharmacology and pharmacometrics efforts for various drug development projects.

BiopharmaBiotechnologyPharmaceutical

Hiring Manager

Mohammad Ouranus

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 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

Qualification

Clinical PharmacologyPharmacokineticsPharmacometricsRegulatory SubmissionsData AnalysisModelingSimulationLeadershipCommunication SkillsCollaborationAttention to Detail

Required

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