Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.
is seeking a Clinical Trial Manager to play a key role on a highly dynamic cross-functional team. Reporting to a Sr. Director of Clinical Operations, you will be responsible for supporting the advancement of rare disease clinical trials as part of Clinical Operations team.
- Support the study feasibility and site selection process and in conjunction with the Sr. Director Clinical Operations.
- In collaboration with Sr. Director Clinical Operations, develop study operational strategies including vendor outsourcing approach.
- Assist with management of CROs and third-party vendors in line with study and program including reporting metrics
- Review of study plans and documents to ensure compliance with GCPs, vendor and in-house procedures.
- Participate in site initiation visits
- Participate in co-monitoring visits with the CRO
- Assist clinical sites with questions and resolving queries.
- Ensure complete and inspection ready throughout the duration of clinical trials
- Support management of study level budgets.
- Support development and follow through of effective clinical and safety data review plans throughout the study; as well as supporting development and implementation of corrective action plans to ensure good data quality.
- With oversight from the Sr. Director Clinical Operations, provide support to the multifunctional team and manage vendors to develop aggressively realistic timelines and ensure appropriate accompanying risk mitigation plans.
- Create and improve upon business processes ensure 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, biostatistics, medical writing, drug safety, regulatory affairs, and legal considerations.
- Deep understanding of clinical trial operations and management of clinical trials at investigator sites
- Multitasking ability to oversee 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
- The position is located at New Yorkoffice
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic and international travel is required (up to 50%)