Axle Informatics

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Job Locations US-MD-Rockville
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).   Overview 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), Therapeutics Research Program (TRP), TB Clinical Research Branch, Rockville, MD. Responsibilities - Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of HIV/AIDS, its co-infections and/or related co-morbidities. 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 clinical expertise to assist in developing Investigational New Drug (IND) applications. Individuals providing this expertise will be named as reviewer of information relevant to the safety of the drug in question, on line 15 and 16 of the IND application (FDA Form 1571). - Evaluate annual IND annual reports for medical safety and report findings to RAB. - 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. - Provide clinical and scientific information for preparing NIAID communications to the Food and Drug Administration (FDA), other government and nongovernmental agencies, pharmaceutical companies and Data Safety Monitoring Boards. - Conduct site visits, when necessary, to obtain additional data and information for use by federal staff in the consideration and evaluation of ongoing and future programs. - Preview serious adverse event (SAE) reports providing expert medical advice for potential impact of SAEs in ongoing research and participate in the preparation of reports submitted to the FDA. - Attend and participate in national/international scientific meetings/conferences in order to stay abreast of current research findings and to interact with other investigators to promote collaborations. Experience Required / Requirements - MD or equivalent degree; active Medical license preferred. - Completed training in Internal Medicine or Pediatrics. - Training in Infectious Diseases or Pulmonary Medicine preferred. - Board Certification in Internal Medicine or Pediatrics, Infectious Diseases, or Pulmonary Medicine preferred. - Experience in in clinical trials, especially TB or other infectious diseases preferred. - Experience in TB clinical care or studies preferred. Benefits - Paid Time Off (PTO) - 10 Paid Federal holidays - Generous health coverage provided with no monthly premium to the employee - Generous vision and dental coverage provided with no monthly premium to the employee - Short and Long-Term Disability coverage (paid by company) - Basic Life and AD&D coverage (paid by company; option to purchase additional coverage) - 401(K) with significant company match & no vesting period - Competitive salaries with performance bonus opportunities - Discount plan for pet care, legal services, & identify theft protection - 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:  Email: careers@axleinfo.com   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.
ID
2020-1732
Job Locations US-MD-Bethesda
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).   Overview Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Biologist/Flow Cytometry Specialist  to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Immunology Laboratory (IML), Flow Cytometry Core (FCC) as well as the ImmunoTechnology Section (ITS), Bethesda, MD. Responsibilities - Perform a wide range of complex procedures in the Flow Cytometry Core Laboratory. Specific techniques may include, but are not limited to, monoclonal antibody conjugation, fluorescent dye chemistry, peripheral mononuclear cell isolation, multiparameter flow cytometry, T cell stimulation assays, immunophenotyping, and tissue culture. - Conduct independent research under the guidance of the Chief, Flow Cytometry Core, including planning, and conducting of experiments, data analysis and peer reviewed publication of data. - Coordinate clinical specimen management, including inventory, sampling, and analysis, in support of the clinical research protocols, in support of the ImmunoTechnology Section. - Calibrate and operate a variety of laboratory instruments under standard guidelines and following Standard Operating Procedures to perform test, analyses, and other procedures. - Interact with scientist from other organizations or institutions involved in similar or - related research projects. - Interact with students, post-doctoral fellows and non-doctoral research technicians on experimental design and laboratory-based methodologies. - Train laboratory personnel on optimal use of newly built flow cytometry technologies and ensure that the data obtained by those personnel are appropriately generated. - Maintain accurate, daily records of experiments. - Analyze experimental data, prepare summary analyses for presentation and/or publication, and write substantial portions of manuscripts including such data. Experience Required / Requirements - Bachelor’s and/or Master’s with laboratory-based training in immunology or closely related field. - Extensive experience with all aspects of flow cytometry including instrument standardization, calibration, and assay optimization. - Candidates should have excellent written skills and experience in oral presentations. Benefits - Paid Time Off (PTO) - 10 Paid Federal holidays - Generous health coverage provided with no monthly premium to the employee - Generous vision and dental coverage provided with no monthly premium to the employee - Short and Long-Term Disability coverage (paid by company) - Basic Life and AD&D coverage (paid by company; option to purchase additional coverage) - 401(K) with significant company match & no vesting period - Competitive salaries with performance bonus opportunities - Discount plan for pet care, legal services, & identify theft protection - 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:  Email: careers@axleinfo.com   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.
ID
2020-1714
Job Locations US-MD-Gaithersburg
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).   Overview Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Regulatory Affairs Specialist to join our vibrant team at Gaithersburg, MD. Responsibilities - Responsible for chemistry, manufacturing and controls (CMC) information of all investigational new drug (IND) applications for vaccines, monoclonal antibodies, and related biological products. - Assist regulatory program managers with CMC-relevant responses to comments from regulatory authorities. - Oversee planning, preparation and review of Module 3 sections in Common Technical Document (CTD) format for submission to regulatory authorities. - Ensure documentation follows FDA guidelines and Code of Federal Regulations (CFR). - Interacts collaboratively with VRC Office of Regulatory Sciences and Project Management groups. - Serve as subject matter expert for Vaccine Production Program (VPP) process development staff for raw material sourcing and product testing strategies. - Interact with the VRC pilot plant manufacturing, regulatory and quality assurance staff. - Review and provide comments, recommendations, and strategy on product specifications, stability protocols, comparability protocols and reports, investigator brochures and other related CMC documents during product development of biological products for early phase clinical trials. Experience Required / Requirements - Bachelor’s degree, MS preferred, in life science from an accredited college or university. - Minimum of 8 years progressively responsible experience in Regulatory Affairs. - Must have at least 5 years working with biologics/large molecules CMC preparation in the US. - Must have direct experience assembling Regulatory applications in eCTD format. - Must have demonstrated strong understanding of the U.S. Regulatory requirements. - Must have Expertise in MS Office and SharePoint. Benefits  - 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: Email: careers@axleinfo.com   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.
ID
2020-1692
Job Locations US-MT
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) Overview We are seeking a Bioinformatics Specialistpersonnel to join our team in 903 S. 4th Street, Hamilton, MT 59840. Responsibilities - Utilize experience with bioinformatics, randomized schemes, sample prep technology for High Throughput TaqMan, and next-generation sequencing to work with DNA and RNA isolation reagents while maintaining strict adherence to quality and performance in a wet-bench setting. - Work with a variety of samples including in vitro grown bacteria, tissue culture samples, flow sorted samples, human and animal tissues in RNA-protect, RNALater, or Trizol/phenol-based solutions, for RNA, RNA/DNA, or DNA isolations. - Work with randomized schemes pertinent to the sample processing effort. Work with robotics fluidics stations (Biomek FX, NX) multi-channel pipettors; process single up to 96 and 384 well samples for target preparation for host/pathogen transcriptome profiling. - Prepare sample for High Throughput TaqMan, NGS data generation, High Throughput SNP processing, allelic discrimination assays, and genotyping. - Maintain detailed record of laboratory notebook which describes laboratory protocols/methods followed. - Assist in the writing and publication of peer-reviewed manuscripts and reports associated with work performed. Improve the efficiency and effectiveness of projects and technologies. - Develop and optimize new protocols for the lab. - Assist with Next Generation Sequencing data analysis and data interpretation. - Assist and train postbacs, ITTAs, post -doctoral researchers, high school students regarding the use of equipment/computers/software and for assistance on projects. Requirements - Master’s degree (or foreign equivalent) in Bioinformatics or a related field plus three years of experience reflecting demonstrable ability in the skill set described above.   Benefits - 100% Medical, Dental & Vision premium coverage for Employees   - Flexible Spending Accounts - 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:  Email: hr@axleinfo.com  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.  
ID
2020-1626
Job Locations US-MD-Bethesda
Axle Informatics is a bioinformatics and information technology company that offers innovative computer services, informatics, and enterprise solutions to research centers and healthcare organizations around the globe. With experts in software engineering, bioinformatics and program management, we focus on developing and applying technology tools and techniques to empower decision-making and accelerate the discovery in translational research. 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 Pharmacovigilance Clinical Program Manager to join our vibrant team at Bethesda, MD.   Responsibilities  - Oversee all aspects of the VRC CTP Pharmacovigilance Program, which leads the process for safety signal management activities, and ensure the detection, assessment, understanding and prevention of safety events for each investigational product (IP) the VRC manufactures for clinical research.  - Provide tactical leadership for the VRC CTP Pharmacovigilance Program/Team.   - Create and adapt pharmacovigilance procedures based on prevailing domestic and international regulations, VRC polices/procedures, etc.  - Review safety events for completeness and trends; analyze comprehensive safety data in consultation with PV team; communicate findings to VRC’s Office of Regulatory Sciences.   - Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting guidelines.   - Draft, review and finalize PV data agreements with collaborators who receive VRC-manufactured investigational products.   - Work with VRC’s external partners to gather PV information/data and review it utilizing the PV data system platform (ARGUS).   - Author/provide strategic input or oversight for PV related sections of periodic regulatory documents (i.e. IND annual reports, DSURs, IB updates) according to the agreed process and timelines.   - Monitor and evaluate safety profiles of VRC manufactured investigational products to detect any change in risk profile.   - Collaborate with VRC CTP protocol operations, medical, quality and risk management teams to ensure coordinated and effective risk mitigation strategies throughout the product lifecycle.   - Assign projects and set deadlines for PV Team staff and facilitate PV team meetings.  - Maintain knowledge of vaccine and monoclonal antibody safety profiles and product development status; review relevant biomedical literature or other scientific data.    Experience Required / Requirements   - Clinical Advanced degree (NP, PA, MD, etc.) is required.  - Minimum 3 -5 years’ experience in PV with significant experience in preparing regulatory documents.   - Knowledge of clinical trial and PV methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements in PV  - Experience with MedDRA and drug coding reviews.   - Minimum of 5 to 10 years’ related experience in a biotechnology, pharmaceutical company, government, or CRO environment.   - Strong experience in the conduct and management of clinical trials, especially phase I – III vaccine or monoclonal antibody clinical trials. Strong background in clinical trial drug safety is required  - An understanding of medical terminology and ability to summarize medical information is required.  - Personnel management experience is required.  - Strong attention to detail and follow-up skills is required.   - Must be flexible and willing to take on significant administrative responsibilities.   - Must take initiative and have ability to work independently and as a team member, offering assistance wherever needed.   - Must be able to create contingency plans to deal with possible challenges and roadblocks.   - Good computer and database skills, familiarity with ARGUS platform is preferred.    Benefits - Paid Time Off (PTO) - 10 Paid Federal holidays - Various wellness programs - Employee Referral Bonus Program (ERBP) - Vision coverage through Cigna national network - Dental coverage through Cigna national network - 401(K) with significant company match & no vesting period - Short and Long-Term Disability coverage (paid by company) - Competitive salaries with opportunity for performance bonuses - Discount plan for pet care, legal services, & identify theft protection - Basic Life and AD&D coverage (paid by company; option to purchase additional coverage) - Medical coverage through UHC national network (option to choose between 3 available plans) - 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:                       Email: careers@axleinfo.com   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.  
ID
2020-1511