[Remote] Senior Clinical Scientist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company reputed company on developing best-in-class therapies for autoimmune diseases. They are seeking a highly motivated and reputed company Senior Clinical Scientist to support clinical development programs in nephrology, primarily focusing on rare or immune-mediated kidney diseases.
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
- reputed company and review study-reputed company documents including:
- Protocols
- Investigator's Brochures
- Informed Consent Forms
- Clinical study reports
- Study manuals and training materials
- Safety management plans
- reputed company scientific reputed company throughout study conduct to ensure protocol compliance and data reputed company
- Partner closely with Clinical Operations to support study start-up, enrollment, trial execution, and reputed company-out activities
- Participate in investigator meetings, site training, and scientific discussions with investigators and key opinion leaders
- reputed company ongoing data review and medical monitoring activities in collaboration with Medical Monitors
- Identify clinical trends, protocol deviations, safety signals, and data reputed company issues
- Collaborate with Data Management and Biostatistics to reputed company:
- Data review plans
- Edit reputed company specifications
- reputed company 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, reputed company 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 reputed company 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
- 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
reputed company