Back to Job Search

Principal Clinical Research Scientist

  • Location: San Francisco
  • Salary: US$180000 - US$190000 per annum per year
  • Job Type:Permanent

Posted 20 days ago

  • Sector: Life Sciences
  • Contact: Divna Rosenzweig
  • Expiry Date: 16 October 2022
  • Job Ref: JN -092022-473838

The Principal Clinical Research Scientist will work closely with the Executive Medical Director, Clinical Research and Medical Monitor (or with staff more senior to this position in the Department) to assist and facilitate the work involved in clinical projects including component studies. This role will provide direct regulatory and medical writing support with expanded roles in the following areas, but not limited to, initial through final drafting and/or amendments of: 1) Protocols, ICFs, IBs, CSRs, 2) Summary of key findings after targeted literature review, 3) Table or figure summaries of preliminary and exploratory data analyses (e.g., for DSRC, KOL, external collaborator, translational or other internal meetings), and 4) Publications and any other regulatory or supporting documents. This role may also provide strategic input and participate in the development of clinical operating guides. This role may often act as an editor and key reviewer of the documents listed above instead of the primary medical writer as assigned. Other roles and responsibilities include presenting clinical development information to a science or medical audience, assisting Medical Director with site or CRO interactions, reviewing and summarizing primary research data, acting as an Alliance manager with industry collaborations, and train and mentor early career Clinical Research Scientists.

Responsibilities:

  • Work closely with the Executive Medical Director, Clinical Research and Medical Monitor (or with staff more senior to this position in the Department)
  • Write the first drafts of the scientific or medical components of regulatory documents and clinical trial protocols
  • Write the first draft of publications (abstract and manuscripts) and coordinate review and integration of feedback toward the final publication
  • Interface with groups internal and external to Astex as needed
  • Serve as Alliance manager of industry collaborations as needed
  • Facilitate cross-function collaboration
  • Manage medical writing/clinical operations and clinical development interactions; act as a direct expert resource for medical writing and clinical operations teams
  • Provide strategic input for clinical development plan and regulatory interactions
  • Assist with review of clinical data and data clean up
  • Assist with the development of operational guidelines
  • Lead the consultations and interactions with various stakeholders to help the team with a CDx development plan as needed
  • Assist with IST protocol and data review; review of IST publications
  • Manage and mentor new clinical scientist employees that join Astex in the future

...