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Clinical Scientist – Job Description
Position Summary:
The Clinical Scientist will report to the Medical Director within the Clinical Development function. This individual plays a central role in executing clinical development plans and trial strategies in close collaboration with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and Drug Safety.
The Clinical Scientist provides scientific and operational support across the full lifecycle of clinical trials – from protocol development through study execution, data interpretation, and dissemination of results.
Key Responsibilities:
- Collaborate with the Study Medical Lead to support program clinical development plans, including:
- Planning and execution of clinical trials
- Development of data collection, review, and interpretation processes
- Interpretation and presentation of study data for safety and efficacy assessments
- Partnership with safety teams to support ongoing review and communication
- Preparation of internal and external scientific materials (e.g., DMC/Steering Committee presentations, manuscripts, review articles)
- Contribution to clinical documents including study reports, Investigator Brochures, narratives, and regulatory submissions (e.g., INDs, NDAs, briefing packages)
- Conduct literature reviews and summarize findings to support program decision-making
- Support internal and external training initiatives related to protocol design and clinical development processes
- Serve as a liaison with internal and external experts to align study execution with protocol intent; may lead endpoint-specific or medical training
- Assist with planning and delivery of materials for Investigator Meetings and Scientific Advisory Boards
- Develop and contribute to DMC/adjudication charters and assist in related meetings and deliverables
- Provide cross-functional scientific support to internal teams and partners as needed
Qualifications:
- Bachelor’s degree in Life Sciences or related field required; advanced degree (e.g., MS, PhD, PharmD, RN) preferred
- Minimum of 5+ years of experience in clinical research or drug development
- Hands-on experience in clinical study execution and data review
- Familiarity with domestic and international clinical trial design and reporting standards
- Knowledge of GCP, ICH, and regulatory frameworks
- Strong independent and collaborative working skills, with ability to operate in fast-paced and cross-functional environments
- Demonstrated planning, critical thinking, and time management capabilities
- Excellent communication and presentation skills
- Proficiency in clinical and data tools such as Spotfire®, R, GraphPad Prism, or similar platforms
Physical Requirements:
- Ability to work at a computer or lab bench for extended periods
- Visual and manual acuity for data analysis and keyboard-based tasks
- Occasional domestic and international travel required
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