Clinical Scientist

Responsibilities

• Develop clinical data strategies and independently design assigned clinical studies in collaboration with cross-functional teams (C1 study phase through handoff)
• Lead efforts for the analysis, interpretation, presentation, and reporting of clinical and imaging data to relevant stakeholders
• Author and own the clinical data content within regulatory submissions (IDEs, PMAs, 510(k)s, CE Mark submissions); partner with Regulatory Affairs on submission planning and data response strategies
• Cook with the DSMB in accordance with the DSMB Charter, including data summaries, patient summaries, study notifications, and meeting attendance
• For studies with an imaging component : coordinate receipt, review, and core laboratory selection, training, and management for independent imaging review
• Develop and execute publication and presentation plans for assigned studies in collaboration with relevant stakeholders
• Review and provide input on clinical study documents including CIPs, IBs, CRF specifications, IC templates, progress reports, and study overview presentations
• Support and review materials for Investigator Meetings and Site Initiation Meetings
• Review study data and milestones; coordinate study strategy with cross-functional stakeholders
• Maintain effective communication with cross-functional teams and stakeholders across the study lifecycle
• May provide guidance to Clinical Science Analyst staff on study-specific data tasks

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a closely related field required ; advanced degree (Master’s or PhD) preferred
• Minimum 3 years of clinical research experience, with demonstrated involvement in clinical study design and data analysis
• Working knowledge of GCP guidelines, ISO 14155, and applicable FDA and international regulatory requirements
• Experience with regulatory submissions and clinical evidence documentation preferred
• Proven ability to independently develop clinical data strategies and design clinical studies
• Strong analytical skills with demonstrated ability to interpret complex clinical and imaging datasets
• Working knowledge of regulatory authorities and requirements that may impact global clinical studies
• Excellent written communication skills; experience authoring clinical study documents and regulatory data sections
• Strong verbal communication and presentation skills; ability to effectively engage physician experts and cross-functional stakeholders
• Sound judgment in independent decision-making with appropriate escalation awareness
• Excellent organizational and problem-solving skills; ability to manage multiple concurrent studies and priorities
• Willingness and ability to travel up to 15% of the time