Overview
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 investigators, or other medical experts.
- Support evaluation of clinical safety information, adverse events, protocol deviations, clinical-risk signals, and related documentation in collaboration with Regulatory Affairs, Quality, investigators, and medical advisors.
Regulatory, Quality, and Documentation Support
- Contribute scientific, preclinical, translational, and clinical content to regulatory submissions and related communications.
- Participate in regulatory meetings as one of the Company's scientific/clinical-development representatives, as appropriate.
- Support documentation relevant to design controls, DHF content, risk management, clinical evaluation, preclinical evidence, product lifecycle requirements, and sponsor deliverables.
- Ensure study-related documentation is complete, traceable, scientifically justified, and suitable for regulated product-development use.
- Collaborate with Quality Assurance and Regulatory Affairs to ensure that preclinical and clinical evidence packages are aligned with applicable requirements and expectations.
- Support internal reviews of protocols, study reports, data packages, scientific summaries, manuscripts, abstracts, technical memoranda, and regulatory-support documents.
- Maintain awareness of relevant regulatory and quality frameworks, which may include GLP, GCP, ISO 13485, ISO 10993, FDA Quality System Regulation, 21 CFR Part 4, 21 CFR Parts 210 and 211, and other applicable standards or guidance.
Skills and Experience:
The Director of Preclinical & Clinical Science should possess the following abilities to support medical technology development through clinical evaluation:
- 7+ of relevant experience in medical device, pharmaceutical, and/or combination product translational (preclinical and clinical) research.
- Experience contributing to or overseeing preclinical and clinical study design, protocol development, endpoint selection, study execution, data interpretation, scientific reports, regulatory-support documentation, and cross-functional development decisions.
- Strong understanding of translational research, preclinical study design, clinical-development strategy, and early-stage product evidence generation.
- Experience in trauma, emergency medicine, critical care, resuscitation, hemostasis, military medicine, or related fields preferred.
- Familiarity with FDA-regulated product development, including GCP, GLP, ISO 13485, ISO 10993, IRB processes, IACUC/ACURO processes, and sponsor-side clinical-study obligations preferred.
- Ability to evaluate clinical and preclinical data, including study limitations, biological relevance, clinical significance, data quality, adverse findings, protocol deviations, and risk implications.
- Strong scientific judgment and ability to conceptualize scientific hypotheses, translational strategies, clinical evidence plans, and practical study designs.
- Ability to identify and mitigate product-related clinical, usability, translational, preclinical, and regulatory risks.
- Strong leadership, mentoring, and cross-functional collaboration skills.
- Excellent written and oral communication skills, including the ability to contribute to protocols, technical reports, regulatory summaries, grant proposals, sponsor reports, manuscripts, abstracts, presentations, and internal scientific memoranda.
- Ability to work cross-functionally with scientific, engineering, manufacturing, quality, regulatory, clinical, grants/contracts, and business teams.
- Self-motivated with strong time-management and organizational skills.
- Ability to work independently, prioritize multiple projects, address complex issues, and operate within a fast-paced, hands-on environment.
- Highly organized, detail-oriented, and capable of maintaining documentation consistent with regulatory requirements
Education and Training:
- Advanced degree required in a relevant scientific, clinical, medical, veterinary, pharmaceutical, biomedical engineering, physiology, neuroscience, translational science, or related discipline.
- Acceptable degrees include PhD, MD/DO, DVM, PharmD, or equivalent advanced scientific or clinical training
- Additional training or experience in clinical research, translational medicine, medical device development, combination-product development, biostatistics, regulatory science, GLP/GCP, human subjects research preferred.
- Authorization to work in the United States indefinitely without restriction or sponsorship is required, subject to any applicable export-control or government-contract requirements.
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:
$160,000 - $200,000 per year
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