Jadebiosciences

Senior Clinical Scientist

Boston; Remote; San Francisco; Vancouver. Posted 3 months ago

The role

The Senior Clinical Scientist will support clinical development programs in nephrology with a focus on rare or immune-mediated kidney diseases. This person will translate clinical strategy into the execution of late-stage phase clinical trials.

What you will do

  • Serve as the Clinical Scientist for one or more Phase 2 and/or Phase 3 clinical studies.
  • Contribute to study design, protocol development, and protocol amendments.
  • Develop and review study-related documents including protocols, Investigator's Brochures, Informed Consent Forms, clinical study reports, study manuals, and safety management plans.
  • Provide scientific oversight throughout study conduct to ensure protocol compliance and data quality.
  • Partner with Clinical Operations to support study start-up, enrollment, trial execution, and close-out activities.
  • Participate in investigator meetings, site training, and scientific discussions.
  • Lead ongoing data review and medical monitoring activities in collaboration with Medical Monitors.
  • Identify clinical trends, protocol deviations, safety signals, and data quality issues.
  • Collaborate with Data Management and Biostatistics to develop data review plans, edit check specifications, and endpoint derivation and analysis plans.
  • Support preparation of regulatory submissions and agency interactions.

Required qualifications

  • Advanced degree in life sciences, nursing, pharmacy, public health, or related discipline (PharmD, PhD, MS, MPH, or equivalent)
  • Minimum 5–8 years of clinical research experience in the biotechnology, pharmaceutical, or CRO industry
  • Experience supporting Phase 2 and/or Phase 3 clinical trials
  • Strong understanding of clinical trial design, clinical data review, and drug development
  • Working knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
  • Experience reviewing clinical data and collaborating with biostatistics and data management teams
  • Excellent project management, communication, and organizational skills
  • Ability to work independently and manage multiple priorities in a fast-paced environment

Nice to have

  • Experience in nephrology, immunology, inflammation, autoimmune diseases, or rare diseases
  • Experience with global multicenter clinical trials
  • Prior involvement in regulatory submissions and health authority interactions
  • Experience contributing to scientific publications and conference presentations
  • Experience working in a small or emerging biotechnology company

About the company

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. The company was launched based on assets licensed from Paragon Therapeutics.

Senior Clinical Scientist at Jadebiosciences | JobZoey