Clinical Scientist

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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