Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Senior Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), Vaccine Research Center (VRC), Office of Regulatory Science (ORS), Bethesda, MD.
- Provide recommendations on optimal non-clinical strategies to advance candidate products to the clinic.
- Work closely with cross-functional groups to formulate non-clinical proof of concept and toxicology testing strategies prior to the start of any IND-enabling activities to ensure that the studies are meeting the program’s needs and are designed to fulfill regulatory requirements.
- Communicate regulatory information to multiple departments and ensure that the information is interpreted correctly.
- Successfully interact with other functional area experts in a project team environment to recommend the best course of preclinical development for a given program and explain those recommendations to VRC Leadership.
- Facilitate communication and collaboration internally and/or externally (i.e., vendors/CRO) to ensure mutual clarity amongst multidisciplinary teams and accuracy and suitability of documents/reports for regulatory submission.
- Maintain current knowledge of relevant domestic and international regulations, including proposed final rules and guidance documents.
- Review and approve toxicology protocols and review non-clinical protocols for completeness and compliance with FDA current Good Laboratory Practice (GLP) and applicable regulations.
- Develop and integrate timelines for non-clinical activities with overall program timelines and VRC goals, in close coordination with Program Management, CMC, Clinical, Regulatory groups and other stakeholders.
- Work together with Regulatory personnel and subject matter experts to author relevant sections of regulatory submission documents (pre-IND and IND) as well as the nonclinical section of Investigator’s Brochures.
- Prepare and/or review all IND non-clinical reports, including toxicology reports from vendors/CRO for submission to the regulatory authorities.
- Provide responses to regulatory agencies comments regarding non-clinical research or potential pre-IND and IND submission issues.
- Collaborate with strategic planning group during contract negotiation to provide insight and guidance regarding scope of work pertaining to non-clinical/toxicology studies.
- Oversee CROs and other external resources and ensure quality results are delivered. This includes study design, protocol development, coordination of study materials, data interpretation, report review and approval.
- Develop and maintain SOPs, in collaboration with relevant subject matter experts, for non-clinical/toxicology studies, including their review and approval processes.
Experience Required / Requirements
- PhD in toxicology, biology/pharmacology, with at least 10 years related experience with vaccines and other biologics.
- American Board of Toxicology (DABT) required.
- Regulatory Affairs Certificate preferred.
- Experience specifically supporting drug discovery research and development from a toxicology standpoint.
- Experience in designing, conducting, monitoring and interpreting nonclinical toxicology/research studies.
- Demonstrated success managing interactions with external CROs, consultants and other contract organizations is a plus.
- Working knowledge of GLP regulations, ICH, and other regulatory guidance documents, and experience conducting and monitoring toxicology studies is critical.
- Excellent organizational, interpersonal and verbal/written communication skills and ability to perform as an effective, flexible and self-assured team player.
- 100% Medical, Dental & Vision premium coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.