Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.
The Clinical Operations Manager will report to the Director, Clinical Operations and will collaborate with cross-functional groups to develop and maintain business processes to ensure the Nonclinical and Clinical teams are innovative and adaptive in Immunovant’s approach to drug development while also compliant with regulatory expectations.
Vendor Management & Governance:
- Drive the governance and oversight process for Clinical and Non-Clinical vendors, including but not limited to: CROs, bioanalytical labs, and vendors providing patient recruitment, site optimization, and home nursing services, etc.
- Lead the maintenance of KPI scorecards across the R&D department
- Explore new vendors and innovative capabilities for the clinical team
- Partner with Clinical, Nonclinical, Quality, and Regulatory teams in the development, monitoring, and continuous improvement of the GXP quality system, including SOPs, document management, personnel training, and quality processes
- Ensure timely completion of preventative and corrective actions associated with the company’s Quality Plan
- Each year, assess all SOPs for applicability to current regulations and revise as needed, incorporating input from subject matter experts
- Monitor the R&D team’s compliance with SOPs, prepare mitigation plans to resolve any instances of non-compliance, and monitor the execution and adherence to such plans
Other Project Management:
- Support the R&D organization on confidentiality agreements, consulting agreements, scopes of work, and other contracts
- Support the preparation for ad-hoc clinical and medical meetings (e.g. investigator meetings, site coordinator meetings, and advisory meetings)
- Ensure timely completion of clinical commitments across trials as required by regulators
- Contribute to other ad-hoc initiatives with clinical trial teams as needed (with flexibility to take on additional responsibilities in areas of personal interest)
- Bachelor’s degree required; degree with a focus in biological science
- Minimum of 3 years of progressive experience in clinical trial operations either at a sponsor or CRO
- Experience in project management is required
- Familiarity with clinical trial documentation including protocols, investigator brochures, and informed consent forms • Strong knowledge in GCP and ICH and of the application process to conduct clinical trials
- Ability to function in a fast-paced, dynamic environment
- Ability to deal with ambiguity
- Strong interpersonal skills
- Proven complex problem solver with strong decision-making and analytical skills
- Demonstrated self-starter and team player
- Excellent written and verbal skills
- Immunovant’s headquarters is located in New York City. The position is flexible for remote work.
- Dynamic, interactive, fast-paced and entrepreneurial environment
- Domestic or international travel may be required (<10%)