Clinical Development Scientist, Manager–Inflammation and Immunology (I&I)

Clinical Development Scientist

You will support the development and execution of one or more less complex studies for small molecule and/or novel biological therapies in the I&I therapeutic area. You may participate as an individual contributor (often in partnership with and/or under the mentorship of a more senior Clinical Development Scientist) on clinical study teams to support enrollment and study delivery timelines. You will work with other functional disciplines as needed (e.g., Clinical Operations, Global Clinical Leads/Medical Monitors, Biostatistics/Data Management, Clinical Pharmacology, and Digital Medicine). You may be a member of clinical sub-teams to ensure collaboration and seamless connectivity across functions.

Position Responsibilities

• Support the development and execution of simple to minimally complex clinical studies; on more complex studies, support a more senior Clinical Development Scientist by taking responsibility for assigned components of the overall clinical team's deliverables.
• Support the preparation and review of study-related documents, including but not limited to clinical protocols, informed consent documents, and study training materials.
• Support clinician data review activities; on more complex studies, work with a more senior Clinical Development Scientist to collect and collate safety data for safety review meetings and ongoing monthly data reviews in accordance with the data review plan.
• Provide technical support for clinical issues raised by internal and external collaborators, investigators, consultants, and contractors in collaboration with the Global Development Lead (GDL), as needed.
• Collaborate with the study team to maintain open and transparent communication and support successful study completion.

  Minimum Qualifications

  • PharmD/PhD in a related discipline OR
  • MS/MA/MSN and 2+ years of related industry clinical study experience OR
  • BS/BA/BSN and 4+ years of related industry clinical study experience
  • Comprehensive knowledge of GCP and ICH guidelines.
  • Good understanding of the pharmaceutical/biopharmaceutical environment and drug development
  • Strong communication and interpersonal skills.
  • Proficiency in Microsoft Office applications, including Word, PowerPoint, and Excel.

    Preferred Qualifications

    • Experience in a clinician-type role or clinical operations-type role including experience executing clinical studies
    • Project Management experience

      Relocation support available Work Location Assignment–Hybrid– Will work on-site an average of 2.5 days per week and must live within commuting distance to the site.