Job Description

Job Description

Job Description

(ID: 2025-0638)

Axle 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 nationally and abroad. 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 an accomplished and technically driven IT Manager to lead the development of a Repository and Portal supporting the NIH-funded Standardized Organoid Model (SOM) Coordination Center . The role will involve both the reuse of existing software and the development of new software solutions, with potential management of software subcontractors. The IT Manager will also hold responsibility for ensuring FISMA security compliance.

Benefits We Offer:

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

Overview:

This position will oversee the creation of a secure, scalable Organoid Model and Assay Results Portal, including Standardized Operating Procedures (SOPs). The portal will enable researchers to search, select, and request organoids for scientific or commercial purposes, supported by contextual data on model development and performance. The Manager will participate directly in the Authorization to Operate (ATO) process and will guide the long-term security architecture and compliance posture required to sustain the Coordination Center's mission of enabling organoid development through sample resourcing, clinical data integration, data standardization, sharing, and cross-institutional collaboration. The IT Manager will lead the technical execution of the NIH-funded SOM Coordination Center Repository, including s ecurity planning.

• Oversee the development of a centralized research repository and portal to support submission of clinical, assay, and omics data, along with a clinical data acquisition system.
• Ensure the repository and portal reflect available organoid models and support submission of requests for use.
• Ensure the portal contains the SOPs used for organoid development and qualification.
• Lead the internal software development team through the Authorization to Operate (ATO) process, preparing documentation such as:
  • System Security Plans (SSPs)
  • Security Assessment Reports (SARs)
  • Plans of Action and Milestones (POA&Ms) in alignment with NIST SP 800-53, FISMA, and NIH security requirements.
• Manage subcontractors and vendors as needed, including drafting and negotiating Statements of Work (SOWs), monitoring deliverables, and ensuring compliance with contractual terms and performance standards.
• Serve as a liaison across scientific, technical, and compliance stakeholders, translating complex program needs into actionable technical strategies.
• Ensure that both SOM and Coordination Center efforts are securely architected, delivered on time, and aligned with NIH expectations.
• Work closely with the SOM Analytics Team to ensure technical systems align with analytical and scientific workflows.

• Bachelor's degree in Computer Science, Cybersecurity, Health Informatics, or related technical field (Master's preferred).
• At least seven years of progressive IT leadership experience, including work in NIH or other federally funded research environments.
• Demonstrated expertise in managing Authorization to Operate (ATO) processes and navigating federal security frameworks such as NIST SP 800-53 and FISMA.
• Strong track record in developing and managing technical subcontracts, creating Statements of Work (SOWs), and overseeing project deliverables.
• Experience with web application development, cloud infrastructure platforms (AWS, Azure), and clinical or research data system integration.
• Familiarity with API development and JSON, as well as regulated environments including HIPAA and 21 CFR Part 11.
• Knowledge of identity and access management (IAM) systems and role-based access control (RBAC) for secure data environments.
• Working knowledge of biomedical data standards (e.g., HL7 FHIR, CDISC, GA4GH) to support interoperability and data exchange.
• Strong communication skills, with the ability to translate complex research and security requirements into actionable technical plans.

• Relevant certifications such as PMP, CSM, CISSP, CAP, or CISA.
• Experience with RedCap, LIMS, or similar research/clinical data systems.
• Proficiency with tools such as Jira, Confluence, GitLab, and automated compliance documentation platforms.
• Familiarity with FedRAMP standards and DevSecOps practices, including containerization and orchestration (e.g., Docker, Kubernetes).
• Experience supporting federally funded biomedical repositories or consortia (e.g., dbGaP, HuBMAP, Cancer Genomics Cloud).
• Proven ability to lead and mentor multidisciplinary IT teams, manage budgets, and support multi-institutional collaborations.
• Awareness of emerging trends in biomedical informatics, cloud-native deployment, and AI/ML integration for research applications.
• Exceptional ability to synthesize and convey complex technical, regulatory, and scientific concepts to both technical teams and non-technical stakeholders.

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals 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.

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 on 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: careers@axleinfo.com

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location.

#INDPSD

Salary Range

$165,000—$190,000 USD

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