Director of Preclinical & Clinical Science

About the role

The Director of Preclinical & Clinical Science is responsible for guiding Critical Innovations' preclinical, translational, and clinical-development strategy across the Company's product-development lifecycle. This role provides scientific leadership for preclinical research, translational evidence planning, early clinical-development strategy, clinical-study readiness, and scientific support for regulatory and sponsor-facing activities. The Director will lead the Company's Preclinical & Clinical Science function and will spearhead growing a team to provide this company capability. The role requires the ability to translate product-development questions into scientifically sound preclinical and clinical strategies, evaluate clinical relevance and evidence sufficiency, and coordinate effectively with internal and external subject matter experts. The Director will support the design and oversight of preclinical and clinical studies, including studies conducted through external CROs, testing laboratories, clinical sites, investigators, consultants, universities, military facilities, or other collaborators. The role will contribute to study strategy, protocol development, endpoint selection, data interpretation, scientific reporting, regulatory-support documentation, and sponsor-facing technical communications. The Director of Preclinical & Clinical Science ensures that scientific, preclinical, translational, and clinical work is aligned with applicable regulatory expectations for medical devices, pharmaceuticals, and combination products. Relevant frameworks may include FDA's Quality System Regulation, cGMP requirements, GLP, GCP, ISO 13485, ISO 10993, design controls, risk management, human subjects protections, and applicable clinical-study requirements. This position is designated as a full-time on-site role and is expected to be performed primarily at the Company's assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law. Reports to: CEO Duties and Responsibilities: The responsibilities of the Director of Preclinical & Clinical Science typically include the following. Scientific, Preclinical, and Translational Leadership Lead the Company's preclinical, translational, and clinical-development science strategy for medical device, pharmaceutical, and combination-product programs. Oversee and support scientific research activities performed by or for Critical Innovations, including preclinical studies, translational research, biomarker planning, bench studies, cadaver studies, animal studies, and clinical-readiness activities. Provide management support to personnel within the Preclinical & Clinical Science branch. Translate product-development questions into scientifically sound preclinical and clinical evidence strategies. Ensure preclinical research, including bench testing and animal studies, is aligned with clinical feasibility, regulatory expectations, product requirements, and intended clinical use. Oversee or substantively contribute to preclinical study protocols, translational plans, testing strategies, endpoint selection, data analyses, scientific reports, and regulatory-support documentation. Evaluate the scientific quality, clinical relevance, biological plausibility, statistical rationale, and regulatory appropriateness of proposed studies. Identify study risks, scientific limitations, documentation gaps, and evidence deficiencies before execution. Interpret preclinical and translational data in the context of product development, risk management, regulatory strategy, clinical feasibility, and sponsor deliverables. Clinical Development and Clinical-Study Leadership Lead early clinical-development strategy, including clinical rationale, clinical-use case definition, endpoint selection, eligibility criteria, study design, and evidence-generation planning. Support the design, planning, execution, and oversight of sponsor-led clinical studies. Assist with the development and review of clinical protocols, investigator materials, informed consent forms, clinical study plans, clinical sections of regulatory submissions, and clinical-study reports. Provide clinical and scientific input for device usability, human factors considerations, training materials, clinical-use risk assessments, and product-performance claims. Coordinate with investigators, clinical sites, CROs, monitors, statisticians, consultants, medical advisors, regulatory personnel, and other external partners. Ensure appropriate oversight of outsourced GCP studies, including study conduct, documentation, monitoring follow-up, protocol deviations, adverse event workflows, data quality, and closeout activities. Coordinate with qualified medical monitors, physicians, clinical

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Company Intel

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