Preclinical Scientist

Overview The Preclinical Scientist will coordinate, scientifically plan, analyze, and document preclinical studies for the Company. The role is intended for a scientist with graduate-level training and sufficient scientific judgment to translate product-development questions into practical, defensible preclinical study designs, while working with internal and external senior subject matter experts as needed. The position will coordinate and scientifically support a range of primarily live-animal preclinical studies, and may also include related microbiology, animal cadaver or foodstuff testing, human cadaver testing, histopathology, biocompatibility, bench performance, and other translational studies. Most studies are expected to be performed off-site through external Contract Research Organizations (CROs), testing laboratories, universities, military facilities, or other subcontractors. Limited travel may be required for study initiation, in-life observations, troubleshooting, data review, or vendor oversight. In addition to coordinating study logistics, this position is responsible for providing scientific thinking and analysis across preclinical programs. This includes helping select appropriate animal models and endpoints, developing and reviewing scientifically sound protocols, anticipating study limitations, evaluating biological and statistical relevance, interpreting data in the context of device and combination-product development, and communicating conclusions to cross-functional teams. Preclinical Scientist will serve as the coordination point for preclinical studies and will routinely coordinate with: Internal to Critical Innovations Production & Engineering (e.g., test devices, control devices, IFUs) Quality Assurance & Regulatory Affairs (e.g., study regulatory requirements, reporting review) Technical Operations, including the R&D Laboratory and CMC functions, for assay development, laboratory protocols, analytical methods, specimen processing, and CMC-related study support. Grants & Contracts, including contract-driven program management, milestone tracking, sponsor reporting requirements, and deliverable coordination. Shipping and receiving (e.g., to send and receive control and test items, as needed) External to Critical Innovations Contract Research Organizations (e.g., performance of studies) Testing laboratory sites (e.g., testing setup, performance of specific tests on study specimens, histopathology) Statisticians, consultants, and other subcontractors Military subject matter experts and/or facilities (as applicable) This job will encompass the design, development, implementation, oversight, and management of a variety of preclinical animal studies of Critical Innovations' products to ensure study goals (e.g., safety, efficacy, performance, biocompatibility) are met. It additionally includes the analysis of data received from the studies, as well as communicating findings internally and documenting them in applicable Design History Files in compliance with ISO 13485. Additionally, this position includes providing data and analysis for authorship of manuscript, abstracts, presentations, and intellectual property. Familiarity and previous experience with relevant Regulatory requirements for devices and combination products that are either device- or drug-led (e.g., FDA's Quality System Regulation 21 CFR Part 820, Good Laboratory Practices (GLP), ICH, cGMP for pharmaceutical products 21CFR Parts 210 and 211), Quality Management System ISO 13485:2016, ISO 10993 Biocompatibility are a significant benefit. The ideal candidate will be able to think critically, identify study risks before execution, recognize scientific and documentation gaps, and communicate complex scientific findings in a practical manner for engineering, regulatory, quality, clinical, and management audiences. This position is expected to provide meaningful scientific input and independent analysis while also remaining hands-on with study coordination and execution. This position is designated as an 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 Reports to: Director of Preclinical & Clinical Science Duties and Responsibilities The responsibilities of the Preclinical Scientist typically include: Contribute to preclinical study planning, including model selection, endpoint definition, experimental controls, success criteria, sample size rationale, and study-risk assessment. Develop, review, and refine animal models and related test methods, in conjunction with internal and external expertise, to demonstrate product safety, efficacy, performance, usability, durability, biocompatibility, or mechanism of action. Author and/or assist with scientific review of study protocols, amendments, data collection forms, study plans, acceptance criteria, final reports, regulatory submission sections, abstracts, manuscripts, presentations, and internal technical memoranda. Participate in cross-functional preclinical strategy discussions and help translate product-development questions into testable hypotheses and practical experimental designs. Evaluate the scientific quality, regulatory appropriateness, and operational feasibility of CRO and laboratory proposals, including budgets, timelines, methods, endpoints, and deliverables. Obtain quotes, prepare or support purchase orders, supervise subcontracted study work, process invoices, coordinate shipments, and support vendor payment for CROs and related vendors. Coordinate and supervise external study execution, including study kickoff, test article preparation, shipping, in-life monitoring, protocol deviations, issue resolution, specimen handling, pathology review, data transfer, and closeout. Analyze quantitative and qualitative study data; interpret biological, physiological, engineering, histopathological, microbiological, and performance findings; and communicate conclusions, limitations, and recommended next steps. Identify and document study deviations, data anomalies, adverse findings, and technical risks; work with Quality, Regulatory, and Research leadership to determine impact and appropriate follow-up. Support regulatory strategy by preparing or reviewing preclinical testing content for FDA submissions and other regulatory deliverables, including rationale for test selection, GLP status, animal model relevance, and evidence sufficiency. Maintain applicable Design History File documentation, study records, raw data summaries, risk-analysis inputs, technical reports, and traceability to product requirements or program objectives. Collaborate with Research & Laboratory, Production & Engineering, Quality & Regulatory, Grants & Contracts, and external subject matter experts to ensure study outputs meet technical, quality, regulatory, and sponsor needs. Provide scientific input for grant proposals, sponsor reports, peer-reviewed manuscripts, conference abstracts, presentations, patent disclosures, and intellectual property strategy. Support junior staff or coordinators by sharing scientific rationale, protocol-review feedback, data-interpretation input, documentation practices, and vendor-oversight practices. Skills and Experience Sound scientific judgment and ability to apply the scientific method to translational research, device development, and preclinical animal studies. Experience designing, executing, monitoring, coordinating, or analyzing preclinical animal studies, preferably involving medical devices, combination products, trauma, hemostasis, resuscitation, physiology, neuroscience, surgery, critical care, or related fields. Working understanding of experimental design, appropriate controls, endpoint selection, biological variability, bias reduction, data integrity, and interpretation of preclinical findings. Ability to perform scientific data analysis, including descriptive statistics, graphical data review, outlier assessment, study-limitations analysis, and interpretation of statistical output. Excellent written communication, including the ability to author or substantively contribute to protocols, technical reports, regulatory summaries, manuscripts, abstracts, and internal scientific summaries. Strong oral communication and ability to present scientific information to cross-functional technical and non-technical audiences. Experience interacting with CROs, testing laboratories, vendors, consultants, pathologists, veterinarians, statisticians, government sponsors, or academic collaborators is preferred. Familiarity with one or more quality or compliance frameworks relevant to preclinical development, such as GLP, GMP, ISO 13485, FDA Quality System Regulation, ISO 10993, IACUC, ACURO, ICH, or related standards. Ability to work within controlled-document, design-control, and quality-system expectations, including disciplined document review, change control, traceability, and record retention. Strong project-management capability, including schedule management, vendor oversight, issue escalation, milestone tracking, and completion of deliverables under defined timelines. High attention to detail and ability to identify discrepancies, scientific inconsistencies, missing controls, unsupported conclusions, and documentation gaps. Self-motivated, highly organized, and able to work independently while coordinating effectively with a cross-functional team. Proficiency with Microsoft Office Suite. Experience with statistical, graphing, reference-management, electronic data capture, or quality-management tools is beneficial. Ability to travel occasionally for CRO site visits, study observations, sponsor meetings, or vendor oversight. Education and Training Master's degree or PhD in biology, physiology, neuroscience, veterinary science, biostatistics, or a related scientific discipline required. PhD preferred. For candidates with a Master's degree, typically 3+ years of relevant preclinical, translational research, medical device, biotechnology, pharmaceutical, or CRO experience is expected. For candidates with a PhD, relevant graduate, post-graduate, industry, CRO, translational, or applied preclinical research experience is expected; industry experience is preferred but not required. Direct experience with preclinical animal study procedures, IACUC or ACURO submissions, GLP or non-GLP study justification, and external CRO oversight is preferred. Knowledge or experience with FDA preclinical expectations for medical devices or combination products, ISO 13485, ISO 10993, 21 CFR Part 820, 21 CFR Part 58, and/or 21 CFR Parts 210 and 211 is preferred. Authorization to work in the United States indefinitely without restriction or sponsorship is required. Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law. To conform to U.S. Government Department of War regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State. Benefits 401(k) Safe Harbor Plan Healthcare Insurance: Medical, Dental and Vision Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave Tuition Reimbursement Program Performance Bonus Incentive Unit Plan Flexible Schedule Lunches, Snacks, Events Schedule: Monday to Friday Salary: $115,000 – $155,000 per year #J-18808-Ljbffr Critical Innovations