Director of Preclinical & Clinical Science

Overview

The Director of Preclinical & Clinical Science is the scientific and medical executive responsible for guiding Critical Innovations’ scientific strategy, translational direction, clinical development, and medical oversight across all stages of the product lifecycle. This includes scientific leadership of preclinical research, development of translational and biomarker strategies, design and oversight of clinical studies, and medical contributions to the development of the Company’s medical products.

As a licensed physician, the Director of Preclinical & Clinical Science manages the Company’s medical science, providing clinical justification for development decisions, overseeing medical safety during clinical studies, and ensuring that device usability, human factors considerations, risk management, and product performance align with clinical needs and patient safety requirements. The Director of Preclinical & Clinical Science ensures all scientific, preclinical, translational, and clinical work is aligned with applicable regulatory expectations for pharmaceuticals, medical devices, and combination products.

The Director of Preclinical & Clinical Science also serves as Principal Investigator (PI) or as Co-Principal Investigator (Co-PI) for select grants/contracts, providing scientific and medical leadership for externally funded programs, overseeing technical direction, and serving as the scientific and clinical point of contact for sponsoring agencies.

This position requires a comprehensive understanding of preclinical research, translational medicine, and early-phase clinical development. The role also requires familiarity with relevant quality and regulatory requirements such as FDA’s Quality System Regulation (21 CFR Part 820), cGMP for drug products (21 CFR Parts 210 and 211), combination product regulations (21 CFR Part 4), GLP, GCP, and applicable ISO standards (e.g., ISO 13485). The Director of Preclinical & Clinical Science must be able to work independently while participating in cross-functional leadership and executive decision-making.

This is an on-site full-time position within Leadership. Time at 80% (with benefits) may be considered to accommodate for part-time clinical work.

Reports to:

CEO

Duties and Responsibilities:

The responsibilities of the Director of Preclinical & Clinical Science typically include the following.

Principal Investigator Responsibilities

• Serving as PI or Co-PI for federally funded grants and contracts.
• Leading the scientific, technical, and clinical direction of funded programs.
• Assisting with the development of proposals, statements of work, technical reports, and milestone deliverables and their oversight.
• Representing the Company in communications with sponsoring agencies and funders.
• Participating in business development activities in pursuit of future funding.

Scientific and Preclinical Leadership

• Overseeing and supporting scientific research activities performed by or for Critical Innovations, including preclinical studies, translational research, and biomarker development.
• Providing management support to personnel within the Scientific & Clinical department.
• Ensuring preclinical research, including benchtop work and animal studies, is aligned with clinical feasibility and regulatory expectations.
• Overseeing the drafting, review, and approval of preclinical study protocols, translational plans, testing strategies, data analyses, and scientific reports.

Clinical Development and Medical Leadership

• Designing, overseeing, and medically guiding early-phase clinical studies.
• Assisting with the development of clinical protocols, investigator’s brochures, informed consent forms, and clinical sections of regulatory submissions.
• Providing medical input for device usability, human factors engineering, training materials, and clinical-use risk assessments.
• Ensuring proper oversight of outsourced GCP studies in accordance with regulatory requirements.
• Supervising medical oversight for outsourced clinical studies, including oversight of adverse events, safety signals, protocol deviations, and related decisions.

Regulatory Support

• Contributing scientific, preclinical, and clinical content to regulatory submissions.
• Participating in regulatory meetings as one of the Company’s medical and scientific representatives.
• Overseeing medical and scientific documentation relevant to design controls, risk management, and product lifecycle requirements.

Skills and Experience:

The Director of Preclinical & Clinical Science should possess the following abilities to support medical technology development through clinical evaluation:

• 5+ years of experience in biotech, pharmaceutical, and/or medical device clinical development preferred.
• Experience serving as a Principal Investigator (clinical, translational, or grant-funded programs) preferred.
• Excellent written and oral communication skills.
• Demonstrated creativity to conceptualize scientific hypotheses, clinical strategies, and translational approaches.
• Strong clinical judgment and ability to interpret medical and scientific data.
• Ability to identify and mitigate product-related clinical and usability risks.
• Strong leadership capabilities.
• Proficiency in analyzing clinical and preclinical data
• Ability to work cross-functionally with scientific, engineering, manufacturing, and quality/regulatory teams.
• Self-motivated with strong time management and organization skills to ensure completion of tasks within strict timelines.
• 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 detailed documentation in compliance with GLP, GCP, ISO 13485, and FDA regulatory requirements.

Education and Training:

• M.D. or D.O. degree required; board certification in a clinically relevant specialty (e.g., Emergency Medicine) preferred.
• Additional training (e.g., Masters or PhD) in relevant field preferred.

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 Defense 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:$200,000 - $260,000 per year

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