Position: Clinical Scientist

JOB DESCRIPTION:

Clinical Scientist supports the assigned clinical study team(s) on one or more clinical studies with various deliverables necessary for effective and efficient clinical development plan execution.  Responsibilities include working in close collaboration with the medical study team in developing and writing protocols, contributing to the planning and organization of studies, reviewing research data, data cleaning in support of clinical development activities. The scientist will work independently on advanced, complex projects requiring the ability to proactively identify and manage risk, have critical thinking skills for the problem solving and have the lateral and strategic thinking capacity to contribute to decisions that affect study outcomes and timelines.

ESSENTIAL DUTIES & RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

  • Demonstrate success, collaborative engagement, technical proficiency and independence for delivering key clinical outputs.
  • Manage and track ongoing study data and participate in regular in-depth data reviews (data cleaning); prepare and present summaries for internal or external study updates.
  • Driving and/or writing key documents in support of drug development projects.
  • Researching current literature, including product labels, treatment guidelines, competitive landscape assessments and standard of care, to assist in the drug development lead(s) in preparation for deliverables.
  • Supporting cross-functional drug development in assembling presentations for deliverables including indication prioritization, clinical development plans and target product profiles, and contributing to the scientific decision making for asset(s) various sections.
  • Assist in the writing documents to support regulatory submissions.
  • Develop templates for key deliverable outputs.
  • Locate, extract, and analyze public and proprietary data to create datasets and outputs that support key drug development deliverables.
  • Assist in the conduct of clinical research studies following established protocols and SOPs.
  • Support with study activities, including investigator recruitment and site selection, enrollment, data collection, drug projections, protocol deviations, and reports.
  • Support with CROs and vendors oversight, as applicable.
  • Manage specialty vendors (specialty laboratories, imaging, etc.) as applicable.
  • Work with development team(s) to resolve subject eligibility and protocol deviation issues.
  • Perform additional tasks and duties as assigned.

REQUIREMENTS:

  • Minimum 3-5 years clinical research experience
  • Masters degree (or equivalent). A PhD or MD is preferred
  • Excellent reasoning capabilities and scientific acumen
  • Proficiency in scientific writing (outlining, drafting, revising, and reviewing)
  • Working knowledge of medical terminology and basic statistical concepts
  • Experience in using and presenting clinical, scientific, or business data to provide evidence for research and decision-making
  • In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
  • Proficiency with software applications including Microsoft Office systems (Outlook, PowerPoint, Word, Excel Teams) and Zoom
  • Disease / therapeutic knowledge preferred

EOE

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.