Senior Clinical Scientist
J
Jade BiosciencesBiotechnology
Location: Boston; Remote; San Francisco; VancouverFull-TimeSenior
Salary175,000 - 190,000 USD per year
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Job Details
- Experience
- Minimum 5–8 years of clinical research experience
- Required Skills
- Project ManagementData management
Requirements
- 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.
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, and clinical study reports.
- 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.
- Lead ongoing data review and medical monitoring activities in collaboration with Medical Monitors.
- Collaborate with Data Management and Biostatistics to develop data review plans and endpoint analysis plans.
- Support preparation of regulatory submissions and agency interactions.
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