Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.

 

Immunovant is seeking a Site & Patient Engagement leader to play a key role on a highly dynamic cross-functional development team. The individual in this role will oversee the strategy, development, and implementation of site and patient engagement efforts across all clinical trials, working cross-functionally with internal teams, CROs, and other third-party vendors to ensure delivery of clinical studies and developing site and patient engagement, recruitment, and retention strategies.

 

KEY RESPONSIBILITIES:

Site Engagement:

  • Develop and maintain relationships with study sites, assist in identification of high performing sites and Key Opinion Leaders that can contribute to forums, boards and/or discussions
  • Manage CRO activities specific to site feasibility and selection - including approval of site selection plan, feasibility questionnaires, and other related documents; attend site selection visits as needed
  • Co-monitor and/or co-audit at sites as needed; reviewing site specific recruitment plans against enrollment
  • Attend key therapeutic and industry trainings/meetings - include organization of meetings with site personnel who may also be in attendance


Patient Engagement:

  • Develop innovative partnerships with patient advocacy groups and the communities they serve; identify opportunities for mutual collaboration such as increasing disease awareness and education
  • Develop understanding of the competitive landscape, identify recruitment hurdles and work with site/CRO on mitigation strategies to ensure delivery of enrollment targets
  • Gain deeper understanding of the patient communities and ensure patients are at the center of what we do and that patient perspectives are reflected in our programs
  • Lead and develop patient advocacy and related advisory boards, working with third party vendors as needed to incorporate patient input into study design and operational strategy with the goal of executing patient-friendly protocols and assessments
  • Lead the design and development of all materials required to implement patient recruitment and retention strategies; train and oversee sites and/or CRO staff in the implementation of patient recruitment and retention strategies
  • Select/coordinate/manage patient engagement/recruitment vendors
  • Integrate patient-centric tools, technologies and processes into Immunovant's clinical development programs


Clinical Operations:

In addition to the above, this individual should have a strong background in clinical operations and be willing to help support all clinical operations activities including but not limited to:

  • Planning, implementation and conduct of clinical studies
  • Contributing to the design, preparation, and finalization of clinical protocols, study manuals, study reports and other key operational/regulatory documents
  • Identification and selection of study vendors including CROs
  • Provide input and oversight of CRO monitoring strategy, including review of monitoring plans, monitoring visit reports, and co-monitoring as needed
  • Serve as an integral member of the Project Team, coordinating activities across functional areas as required


ROLE REQUIREMENTS:

  • Bachelor's degree in Life Sciences/Biological or Health related field
  • 5+ years experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required
  • Previous experience in site and/or patient engagement or an investigator facing role
  • Previous experience in clinical operations - including monitoring, study management, data management, or other operational role
  • Clear and articulate verbal, written and presentation skills - including strong grasp of related scientific and medical terminology
  • Strong facilitation skills, good collaborator, ability to work in networks and matrix organization
  • Results oriented, outcomes focused
  • 'out of the box' thinker with conceptual strengths, who will challenge the status quo to improve
  • Scientific, medical, and technical knowledge, including GCP and regulatory environment
  • Ability to operate effectively within a rapidly changing environment
  • Ability to work independently, to solve problems at all levels of difficulty or uniqueness
  • Regular interaction with various management levels on issues relating to site engagement, patient recruitment, etc.
  • Experience with rare disease / difficult to recruit populations a plus
  • Highly motivated with the ability to be flexible in a fast-paced environment
  • Travel including overnight stays, possibly global, up to 75%