Director, Clinical Research Scientist

Organizational Overview:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases

.
The Rol

e:
In collaboration with a therapeutic area VP of Clinical Development, the Clinical Research Scientist (CRS) will contribute to the design, conduct, analysis, and reporting of clinical trials. The CRS will apply scientific training and clinical research experience to support all aspects of drug development, from facilitating the transition of molecules from pre-clinical discovery to supporting the registration and commercialization of a produ

ct.

Key Responsibilit

• ies:
  
  Contribute to the review, interpretation, and communication of scientific data pertaining to the efficacy and safety of compounds in deve
• lopmentEffectively collaborate with the VP clinical development, the clinical trial manager and the clinical operations manager on all aspects of clinical study development from start to
• finishAttend congresses and review literature to develop and augment expertise in their specific therapeut
• ic areaHelp develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft
• labels.Review competitive landscape and help identify and evaluate business development opport
• unitiesHave responsibility for providing focused scientific and clinical study support from start-up to clinical study report (CSR) and public
• ations.Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to the
• programEngage opinion leader interactions to build pipeline awareness and foster research collabo
• rationsContribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory do
• cumentsContribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study
• conductCollaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial, and medical education strategy for late-stage
• assetsEnsure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in m

eetings
Requi

• rements:
  Advanced degree in Sciences (e.g.MD or equivalent, PharmD, PhD, ) preferred, not required. Advanced masters degree with experience will be co
• nsidered.Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred. (>2 years of experience as a CRS in pharmaceutical industry
• required)Ability to provide input and direction to clinical research with appropriate su
• pervisionStrong desire to collaborate in a cross-functiona
• l settingKnowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study

protocols
Work En

• vironment:
  Dynamic, interactive, fast-paced, and entrepreneurial
• environmentImmunovant’ s headquarters is located in New York City. The position is flexible for r
• emote work.Domestic travel required