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.
Reporting to the (Senior) Director, Clinical Operations, this position should act as a local liaison between Immunovant, CRO CRAs and investigator sites in order to support program specific corporate targets (achieve or exceed), identify and mitigate potential issues and support oversight activities.
The SRM covers multiple Immunovant indications in the assigned country throughout the full life cycle of the trial. Key focus areas are to facilitate optimal clinical trial set-up, execution and quality by:
- Understanding the local environment.
- Create and maintain strong, long-term relationships with sites.
- Support applicable Immunovant Teams in CRO and Sponsor site oversight activities.
Understanding the local environment:
- Obtain relevant knowledge about the assigned region - treatment standards, patient pathways, healthcare system, competitive landscape, clinical trial regulatory environment, patient advocacy groups, Key Opinion Leaders (KOLs), site capabilities and past performance etc.
- Assist applicable Immunovant Teams with creation of country specific plans to target appropriate national patient support/advocacy groups in order to influence patient recruitment.
- Attend local medical/support group meetings and conferences as needed.
- Use local expertise to collaborate closely with applicable Immunovant Teams and CROs and support start-up activities as needed, to ensure high quality feasibility data collected and qualified sites selected.
- Provide input to applicable Immunovant Teams’ site level recruitment targets and recruitment methodologies (enrolment plan).
- Understand local and country regulatory authority and EC requirements to provide support during regulatory and EC submissions and approvals.
Create and maintain strong, long-term relationships with sites:
- Create strong relationships with all relevant site personnel in order to facilitate timely meeting of clinical trial targets (ie, enrollment, data entry, query resolution, etc).
- Site motivation visits to boost screening and enrollment activities.
- Work closely with applicable Immunovant Teams, CRO CRAs and sites to support site enrolment. Understand patient journey at the site in order to ensure that no potential subjects are lost. Create/support site risk plans where applicable.
- Work proactively with sites to resolve/mitigate any issues, share learnings from other sites, and manage any requests in collaboration with applicable Immunovant Teams.
- Keep internal stakeholders oriented about relevant issues and share insights about the sites.
Support applicable Immunovant Teams in CRO and Sponsor site oversight activities:
- Create a close, trustful, and engaged collaboration with counterparts in CRO, in order to have joint strategy for meeting the trial targets. Lead/attend joint regular local/global CRO/SRM meetings.
- Support CRO CRAs and applicable Immunovant Teams to ensure each site’s on time delivery of database lock milestones.
- Based on communication with sites, report/discuss learnings and escalate issues identified to applicable Immunovant Teams. Support any site issue mitigation strategies as needed.
- Support oversight of site-level CRO activities to ensure quality of site and CRO:
- Monitoring Oversight visits to focus on both CRA and site performance. During visit, review previously monitored patients, ensuring compliance with SOPs, protocol, ICH GCP and applicable regulatory requirements.
- Review relevant site-specific metrics to keep track of site performance.
- Follow up with site on any concerns raised by applicable Immunovant Teams.
Site visit expectations:
SRM to visit all sites Face-To-Face when relationship initiated, and as needed throughout the trial. Virtual meetings may be arranged as well. Key sites may be identified to be visited Face-To-Face more frequently than others.
Types of SRM visits:
- Site visits prior to Site Initiation Visit, to ensure site is ready for start-up and help resolve issues hindering activation.
- Site Initiation Visit (CRO CRA owns the meeting, SRM and/or CTM attends as sponsor representative).
- Enrolment booster visits.
- Monitoring Oversight visits.
- Ad hoc site training/re-training visits, as agreed with applicable Immunovant Teams.
- Bachelors or Masters degree in Life Science.
- At least 7 years of experience in the pharmaceutical/Clinical Research industry.
- Minimum 5 years experience as Clinical Research Associate, Monitor or similar.
- Significant experience in clinical research (especially site management) from Pharma, Biotech or CRO.
- Demonstrated experience of working directly with investigator sites and investigators.
- Strong knowledge of ICH GCP.
- Demonstrated relationship building skills with investigator sites (on site and remote).
- Excellent networking skills with internal and external stakeholders.
- Excellent written and verbal communication skills (English and relevant local language(s)).
- Excellent problem-solving skills.
- Self-motivated with proactive issue monitoring and management, including risk assessment and contingency planning.
- Combination of critical thinking and operational expertise and efficiency.
- Experience in clinical trials with rare diseases is preferred.
- Experience in cross-country and cross-functional collaboration is a strong plus.
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Immunovant’s headquarter is located in New York City.
- The position will be located in US, and Canada as a fully remote work position.
- Travel to clinical sites and occasionally Immunovant corporate locations is required (35-50%).