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Roivant Sciences // biomedical research
 
Roivant Sciences, 320 West 37th Street, New York City 10018, United States    Posted: Wednesday, November 06, 2019
 
   
 
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JOB DETAILS
 

Immunovant, a subsidiary of Roivant Sciences, is a clinical stage biopharmaceutical company committed to developing innovative therapies for autoimmune diseases. Our lead asset, IMVT-1401, is in phase 2 clinical development for the treatment of multiple autoimmune diseases, with additional trials expected to start this year.

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, & implementation of site & patient engagement efforts across all clinical trials, working cross-functionally with internal teams, CROs, & other third-party vendors to ensure delivery of clinical studies & developing site & patient engagement, recruitment, & retention strategies.

Key Responsibilities:

Site Engagement:

  • Develop & maintain relationships with study sites, assist in identification of high performing sites & Key Opinion Leaders that can contribute to forums, boards and/or discussions
  • Manage CRO activities specific to site feasibility & selection including approval of site selection plan, feasibility questionnaires, & 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 & 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 & the communities they serve; identify opportunities for mutual collaboration such as increasing disease awareness & education
  • Develop understanding of the competitive landscape, identify recruitment hurdles & work with site/CRO on mitigation strategies to ensure delivery of enrollment targets
  • Gain deeper understanding of the patient communities & ensure patients are at the center of what we do & that patient perspectives are reflected in our programs
  • Lead & develop patient advocacy & related advisory boards, working with third party vendors as needed to incorporate patient input into study design & operational strategy with the goal of executing patient-friendly protocols & assessments
  • Lead the design & development of all materials required to implement patient recruitment & retention strategies; train & oversee sites and/or CRO staff in the implementation of patient recruitment & retention strategies
  • Select/coordinate/manage patient engagement/recruitment vendors
  • Integrate patient-centric tools, technologies & processes into Immunovants clinical development programs

Clinical Operations:

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

  • Planning, implementation & conduct of clinical studies
  • Contributing to the design, preparation, & finalization of clinical protocols, study manuals, study reports & other key operational/regulatory documents
  • Identification & selection of study vendors including CROs
  • Provide input & oversight of CRO monitoring strategy, including review of monitoring plans, monitoring visit reports, & 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
  • 10+ 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 & articulate verbal, written & presentation skills including strong grasp of related scientific & medical terminology
  • Strong facilitation skills, good collaborator, ability to work in networks & matrix organization
  • Results oriented, outcomes focused
  • 'out of the box' thinker with conceptual strengths, who will challenge the status quo to improve
  • Scientific, medical, & technical knowledge, including GCP & 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%
 
 
 
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