Note: The job is a remote job and is open to candidates in USA. Jade Biosciences is seeking a Senior Clinical Scientist to support clinical development programs in nephrology, particularly rare or immune-mediated kidney diseases. The role translates clinical strategy into execution of Phase 2 and Phase 3 trials, including study design, data review, regulatory support, and scientific communication.
Responsibilities
- 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 training materials
- Safety management plans
- Provide scientific oversight throughout study conduct to ensure protocol compliance and data quality
- Partner closely with Clinical Operations to support study start-up, enrollment, trial execution, and close-out activities
- Participate in investigator meetings, site training, and scientific discussions with investigators and key opinion leaders
- 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
- Endpoint derivation and analysis plans
- Participate in database lock, data cleaning, and analysis activities
- Contribute to interpretation of study results and development of key messages
- Support preparation of regulatory submissions and agency interactions
- Assist in development of briefing documents and responses to regulatory questions
- Ensure study conduct aligns with ICH-GCP, applicable regulations, and company standards
- Work effectively across Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety, Medical Affairs, and Medical Writing
- Drive timelines, track deliverables, and proactively identify and mitigate risks
- Support governance meetings and preparation of study review materials
- Contribute to abstracts, presentations, manuscripts, and scientific publications
- Participate in advisory boards, investigator meetings, and key external scientific interactions
- Maintain awareness of evolving scientific, clinical, and competitive landscapes
Skills
- 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
- Strong scientific and analytical thinking
- Attention to detail with a focus on data quality
- Excellent written and verbal communication skills
- Collaborative and team-oriented mindset
- Ability to influence across functions without direct authority
- Comfortably operating in a highly dynamic, entrepreneurial environment
- Proactive, hands-on, and solution-oriented approach
- 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
Benefits
- The role is fully remote.
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