We are seeking a IND/IDE Program Manager (Senior Policy Associate) who will be responsible for the overall implementation and management of the Johns Hopkins University policy and program to support qualification and registration of JHU investigator held INDs and IDEs in accordance with the JHU governing guideline.
The IND/IDE Program Manager will develop and maintain all operational functions that support IND/IDE activities in the Office of Clinical Trials. These operational functions include initial and ongoing qualification of JHU Investigators to serve as the role of sponsor-investigator, evaluation of the suitability of a proposed JHU investigator-sponsor for a specific IND/IDE application prior to submission to the FDA; issuance of letter of suitability or identification of potential areas of concern following an initial evaluation, development of IND/IDE-related policies, procedures, guidances, templates, tools; maintenance of the program's sponsor-investigator assessment tools, databases and intranet site; and provision of administrative support to the IND/IDE c review committee.
This role provides support to address questions of JHU IND/IDE sponsors through the initial application process to the FDA and follow-up correspondence including amendments and reporting. Receives and maintains a copy of relevant correspondence including applicable monitoring reports related to the IND/IDE holder. Develops and reports upon performance metrics for the program. Serves as the liaison between the Office of Clinical Trials and internal partners including the IRB, Office of Policy Coordination (conflict of interest), Clinical Trials Contracting Unit, ORA, Departmental/Divisional leadership and JHU/JHHS compliance monitoring programs; Serves as a liaison with external partners including the FDA.
Specific Duties & Responsibilities:
Manages all components of the JHU sponsor-investigator qualification and suitability process.
Primarily responsible for the initial review of sponsor-investigator qualification submissions and IND/IDE suitability submissions; consults with the Director of Clinical Trials and faculty experts as needed.
Provides guidance to sponsor-investigators and study teams in the development of their submissions to FDA.
Reviews essential documents as needed for regulatory submission including but not limited to initial and amended protocols and any FDA required forms.
Serves as the liaison between the Office of Clinical Trials and internal partners including the IRB, Office of Policy Coordination (conflict of interest), Clinical Trials Contracting Unit, ORA, Departmental/Divisional leadership and JHU/JHHS compliance monitoring programs; serves as a liaison to the FDA, as appropriate.
Develops, reviews, and maintains the program's policies and procedures.
Develops, reviews, and maintains templates, tools, and guidance documents needed for the function of the program.
Evaluates and guides development of sponsor-investigator SOPs and monitoring plans as needed.
Provides support to address questions of JHU IND/IDE sponsors through the initial application process to the FDA and follow-up correspondence including amendments and reporting.
Receives and maintains a copy of relevant correspondence related to JHU sponsor-investigators including applicable monitoring reports.
Manages non-program-specific regulatory projects as requested by the Director, OCT.
Assists monitoring team and provides review of on-going monitoring reports as needed.
Assists with internal and external audits; prepares corrective actions, if necessary.
Administratively coordinates the IND-IDE Review Committee by scheduling meetings, creating agendas, developing meeting minutes, and other administrative support activities as needed.
Maintains current knowledge of regulatory environment especially changes to regulations and guidance documents that are applicable to sponsor-investigator research at JHU.
Creates and delivers IND-IDE workshops, presentations, and other educational materials and opportunities; leverages external training to benefit the program and research activities at JHU; ensures program's objectives are effectively communicated to appropriate stakeholder.
Maintains the program's website.
Participates in long-range planning of the program's activities.
Operates the program within the budgetary parameters and provides recommendations for budget planning; projects expenditures; drafts financial reports.
Performs functions that ensure compliance with institutional policies, state and federal regulations, and requirements of funding agencies.
Performs other related duties as assigned.
Supervision of Others:
Provide oversight of the IND/IDE Specialist.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Minimum Qualifications (Mandatory):
Master's Degree in health-related sciences.
Additional education (graduate level) may substitute for required experience and additional experience may substitute for required education to the extent permitted by the JHU Equivalency Formula.*
Minimum of 3 years of professional experience in clinical research at an academic, government, or pharmaceutical industry environment. Direct experience with the application of IND/IDE regulations required.
Experience and functional knowledge of FDA regulations related to clinical research involving human participants.
Demonstrated ability to work independently and drive processes.
Demonstrated ability to manage projects.
Must be well versed in human subjects research requirements and guidance pursuant to the applicable Code of Federal Regulations (21 CFR parts 50, 54, 312, and 812), the provisions of the HHS Common Rule (46 CFR 45), and ICH GCP (E6) guidelines.
Prefer some knowledge/experience working with GLP and GMP environment.
Prefer experience in regulatory writing- regulatory submission work.
* JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
** Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Licensure, Certification, Registration:
Certification as a Clinical Research Professional helpful
Special Knowledge, Skills, or Abilities:
Must have and exhibit computer skills and possess exemplary writing and verbal skills.
Must have and exhibit attention to detail and excellent organizational skills.
Must have excellent time management skills including the ability to manage multiple and competing priorities.
Ability to work in a team and demonstrated interpersonal skills.
Knowledge of clinical research practices and principles required.
Familiarity with medical terminology and ability to read and digest clinical research materials including clinical trial contracts, research protocols and application materials to the FDA.
Excellent customer service skills including the ability to interact effectively with diverse stakeholders include faculty, research staff and the FDA.
Sitting in a normal seated position for extended periods of time.
Reaching by extending hand(s) or arm(s) in any direction.
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
Communication skills using the spoken word.
Ability to see within normal parameters.
Classified Title: Sr. Policy Associate Working Title: IND/IDE Program Manager Role/Level/Range: ATP/04/PF Starting Salary Range: $81,470 - $111,990 annually (commensurate with experience) Employee group: Full Time Schedule: 8:30 am - 5 pm M-F Exempt Status: Exempt Location: Telecommute Department name: SOM Admin Res Clinical Research Contract Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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