Immunovant

Dedicated to enabling normal lives for people with autoimmune diseases

Senior Director, Clinical Pharmacology

DirectorDirectorFull TimeRemoteTeam 51-200Since 2018H1B No SponsorCompany SiteLinkedIn

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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