To Apply for this Job Click Here

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 trialsDevelopment of data collection, review, and interpretation processesInterpretation and presentation of study data for safety and efficacy assessmentsPartnership with safety teams to support ongoing review and communicationPreparation 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-makingSupport internal and external training initiatives related to protocol design and clinical development processesServe as a liaison with internal and external experts to align study execution with protocol intent; may lead endpoint-specific or medical trainingAssist with planning and delivery of materials for Investigator Meetings and Scientific Advisory BoardsDevelop and contribute to DMC/adjudication charters and assist in related meetings and deliverablesProvide 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) preferredMinimum of 5+ years of experience in clinical research or drug developmentHands-on experience in clinical study execution and data reviewFamiliarity with domestic and international clinical trial design and reporting standardsKnowledge of GCP, ICH, and regulatory frameworksStrong independent and collaborative working skills, with ability to operate in fast-paced and cross-functional environmentsDemonstrated planning, critical thinking, and time management capabilitiesExcellent communication and presentation skillsProficiency 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 periodsVisual and manual acuity for data analysis and keyboard-based tasksOccasional domestic and international travel required P1425266BOSJB_1753386606 To Apply for this Job Click Here