Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
Immunovant is seeking a Clinical Trial Assistant to play a key role on a highly dynamic cross-functional team. Reporting to a Senior Director of Clinical Operations, you will be responsible for administrative support in the advancement of rare disease clinical trials as part of Immunovant’s Clinical Operations team from study start-up to study closure.
- In collaboration with Senior Director Clinical Operations, support the study operational strategies.
- Assist with budget monitoring including invoicing and confirmation of site payments.
- Develop meeting agendas, minutes and track follow-up actions
- Ensure eTMF oversight including routine quality checks to maintain a complete and inspection-ready state.
- Maintain a vendor and site contact list
- Work with the clinical operations team to maintain clinical trial scorecards for routine review
- Assist clinical sites with questions and resolving queries.
- With oversight from the Senior Director Clinical Operations, provide support to the multifunctional team on special initiatives as needed.
- Create and improve upon business processes ensure Immunovant’s successful growth
- BA/BS in a clinical or scientific discipline; at least 3 years of experience with clinical trials; working with a sponsor company (biotech/pharmaceutical company)
- Additional experience in other related fields or positions, some phase 2/3 and global clinical trial experience is a plus.
- Understanding of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, and drug safety.
- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent.
- Understanding of clinical trial operations and management of clinical trials at investigator sites
- Multitasking ability to oversee a large number of projects and reach milestones on time
- Exceptional academic and professional accomplishments, indicating critical thinking ability
- Strong written and oral communication skills with incredible attention to detail
- Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades
- Ability to think outside of the box and challenge the status quo
- Natural entrepreneurial spirit with unrelenting dedication to delivering results
- Desire to work in a fast-paced, innovative environment
- Natural collaborator who enjoys working on a cross-functional team
- Immunovant's headquarters is located in New York City. The position is flexible for remote work.
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic and international travel is required (10%)