Organizational Overview:

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.

The Role:

The Director, North and South American Clinical Operations, drives Immunovant’s clinical site oversight in conjunction with Clinical Development, Clinical Operations and the CRO partner across all Immunovant clinical trial execution in North and South America. This role also partners these groups to define overall strategy toward achieving/exceeding program specific corporate targets, identifying and mitigating potential issues, and ensuring budget and timeline compliance. The incumbent will work with Clinical Operations and the CRO partner to ensure a state of “Inspection Readiness” is maintained. The role also involves direct supervision and mentoring of team members that reside across mainly North America, but also South America, in their support of the clinical sites. 

Key Responsibilities:

  • Develop clinical site strategy for North and South American sites including resourcing, budgeting, project plans, and oversight of North and South American sites to achieve clinical program goals:
  • Partner with Patient Advocacy Director to ensure country specific plans are created to target appropriate national patient        support/advocacy groups to target North and South American patient recruitment
  • Direct the Immunovant North and South American Site Relationship Managers (SRMs) to execute on national patient recruitment plans by use of regional support group meetings and other related activities
  • Direct and manage the Immunovant North and South American Site Relationship Managers to support clinical sites in study set up and execution from the Sponsor’s perspective, as well as monitoring oversight of the CRO’s CRAs. Focus areas for the SRM team will be: understanding of local environment, site relationship building and support in CRO and site oversight activities
  • Ensure SRM team’s adherence to regulatory requirements (ICH, EMA, etc.) and GCP guidelines through establishment, reporting and ongoing optimization of relevant processes (e.g. for monitoring oversight visits). Work with all internal and external stakeholders to maintain a state of “Inspection Readiness”, and support site audit/inspections where necessary
  • Contribute as needed to the preparation and finalization of clinical protocols, PIS/ICFs, IB updates etc.
  • Ensure execution on enrollment plan, risk mitigation, issues management and delivery of high-quality data from the North and South American sites
  • Provide input to the drafting of governance documents, SOPs, work instructions, and other resources
  • Participate in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality or other business objectives
  • Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management and mitigation
  • Collaborate cross-functionally, both internally and externally, to ensure highest quality customer service for clinical sites and patients.  Serve as an escalation point for North and South American clinical sites that have issues with CRO performance or support
  • Establish and nurture relationships with KOLs across the North America and potentially other global regions


Requirements:

  • Bachelors in Life Sciences with an advanced degree preferred
  • At least 15 years of experience in the pharmaceutical industry, with at least 10 years in a clinical leadership role on a cross-functional drug development project team
  • Global experience working across all phases of clinical research (Phases 1-4)
  • Working knowledge of ICH and GCP regulations is required
  • 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
  • Experience in rare disease therapeutic areas and patient engagement strategies preferred
  • Direct supervisory experience
  • Unrelenting dedication to delivering quality results
  • Integrity, in word and action
  • 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


Work Environment:

  • The position will be located in North America
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Travel to clinical sites and Immunovant corporate locations is required (25%)

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