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 Medical Officer to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Vaccine Research Program (VRP), Rockville, MD.
Note: Part-time position; up to 20 hours per week
- Provide medical expertise in the management of COVID-19 disease
- Provide independent review of potential COVID-19 cases in vaccine recipients
- Assist in the development of a standardized assessment to categorize patients positive for COVID illness. The standardized assessment will be developed with input from the Data Safety Monitoring Boards (DSMB), NIAID, Operation Warp Speed, and/or study sponsors
- Participate in discussions with the site-investigators and other federal and non-federal stakeholders
- Communicate with site investigators to get complete data, when necessary
- Respond to questions from the DSMB
- Obtain and compile information, as necessary, for submission of regulatory documents to the US or non-domestic regulatory authorities
- Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of COVID-19. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems that may impede a study.
- Advise program management of merits and deficiencies in proposed clinical studies
- Provide subject matter expertise during protocol development leading to review at the Division level and ensure that the concerns raised during the review are addressed by the Protocol Development Team in a timely manner
- Provide medical expertise in protocol follow-up stages for subject safety and protection, reliability of study endpoint data and make appropriate recommendations to DAIDS’ leadership to ensure trials are conducted according to protocol
- Preview serious adverse event (SAE) reports, provide expert medical advice for potential impact of SAEs in ongoing research and participate in the preparation of reports submitted to the FDA
Experience Required / Requirements
- MD with experience in managing COVID-19 patients (there is no set number of COVID patients that will define experience, but it should be >50) with understanding of disease presentation from outpatient through ICU setting
- Must understand clinical trials and the role of the DSMB
- Cannot have received funding or other have other conflicts of interest with any COVID-19 vaccine manufacturer or trial sponsor (including contracted organizations to the sponsor, i.e. CROs)
- Is not participating in any COVID vaccine trial, or network (including NIAID’s COVID Prevention Network) that is discussing participating in any COVID-vaccine trials
- 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.