Senior Clinical Scientist

Role Overview 

We are seeking a highly motivated and experienced Senior Clinical Scientist to support clinical development programs in nephrology, with a focus on rare or immune-mediated kidney diseases. This individual will play a key role in translating clinical strategy into high-quality execution of late-stage phase clinical trials. This is an exciting opportunity to join a growing biotechnology company where individual contributions have significant impact. The ideal candidate thrives in a fast-paced, collaborative environment, demonstrates strong scientific and operational expertise, and takes ownership of key deliverables. This newly created position will report to the Executive Medical Director of Clinical Development. The role is fully remote and will require periodic travel for investigator meetings, study team meetings, conferences, and other business activities. 

Key Responsibilities 

Clinical Development and Study Execution 

• 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. 

 

Data Review and Interpretation 

• 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. 
   

Regulatory and Documentation Support 

• 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. 
   

Cross-Functional Collaboration 

• 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. 
   

Scientific Communication 

• 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. 

 

Qualifications 

Required