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:
- Study manuals and training materials
- 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:
- 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 - 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.
Preferred - 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.
Skills and Competencies - 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
Position Location This is a remote role; periodic travel to team and company events is required.
The anticipated salary range for candidates for this role is $175,000 - $190,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.
