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.