Clinical Scientist

Regulatory Toolkit; West Lafayette (IN); On-site; USD 120,000 - 170,000; Full time

Job summary

Regulatory Jobs seeks a Clinical Scientist to provide scientific leadership for assigned clinical studies, design data strategies, and lead analysis and reporting of clinical and imaging data in collaboration with Regulatory Affairs, Engineering, and cross-functional teams.

You will author clinical data content for IDEs, PMAs, and other submissions, coordinate DSMB activities, and support publications and presentation plans while traveling up to 15% of the time.

Qualifications

• Bachelor’s degree is required; advanced degree preferred.
• 3+ years of clinical research experience with study design and data analysis.
• Familiarity with regulatory guidelines and submission documents.

Responsibilities

• Develop clinical data strategies and independently design assigned clinical studies with cross-functional teams.
• Lead analysis, interpretation, and reporting of clinical and imaging data to stakeholders.
• Author and own clinical data content within regulatory submissions (IDEs, PMAs, 510(k)s, CE marks); coordinate submission plans.
• Coordinate DSMB data summaries, patient summaries, and meeting attendance.

Skills

Clinical data analysis

Regulatory submissions knowledge

Cross-functional collaboration

Communication skills

GCP & ISO 14155 knowledge

AI/data concepts fluency

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Master’s or PhD preferred

Job description

Overview

This position is responsible for providing scientific leadership and expertise for assigned clinical studies. The Clinical Scientist independently develops clinical data strategy, designs assigned studies, and leads the analysis, interpretation, and reporting of clinical and imaging data. The role partners closely with Regulatory Affairs, Engineering, Business Units, and other cross-functional teams to advance the clinical evidence program.

Responsibilities

• Develop clinical data strategies and independently design assigned clinical studies in collaboration with cross-functional teams (C1 study phase through handoff)
• Develop and maintain relationships with physician experts (e.g., National Principal Investigators, Steering Committee members) to meet clinical program objectives
• 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
• Coordinate the presentation of information to 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
• Provide 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
• This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers
• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position