We are seeking an IND/IDE Program Director 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 Director 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, guidance's, templates, tools; maintenance of the program’s sponsor-investigator assessment tools, databases and intranet site; and provision of administrative support to the IND/IDE review committee . 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, Office of Research Administration, Departmental/Divisional leadership and JHU/JHHS compliance monitoring programs; serves as a liaison with external partners including the FDA, as appropriate.

Specific Duties & Responsibilities

Policy Enforcement

• 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 Senior Associate Dean for Clinical Trials, Director of the Office of Clinical Trials and faculty experts as needed.
• Enforces compliance with the policy by regularly monitoring activities and processes. Identifies areas of non-compliance and take corrective actions.
• Conducts regular audits to assess compliance with policies and procedures. Prepare and present detailed reports on audit findings, and recommend actions to address any areas of concern.
• Regularly reviews the policy to reflect changes in regulations, industry standards, or organizational needs.

Investigator Support

• Provides support to address questions from JHU faculty serving as IND/IDE sponsor-investigators through the initial application process to the FDA and follow-up correspondence including amendments and reporting.
• Provides guidance to JHU faculty serving sponsor-investigators and their research teams in the development of their submissions to FDA.
• Provides guidance for the regulatory submission including but not limited to initial and amended protocols and any FDA required forms.
• Evaluates and guides development of JHU faculty sponsor-investigator SOPs and monitoring plans as needed.

IDE/IND Process Management

• Serves as the liaison between the Office of Clinical Trials and internal partners including the IRBs, Office of Policy Coordination (conflict of interest), Clinical Research Contracting, Office of Research Administration, Johns Hopkins Technology Ventures, Departmental/Divisional leadership and JHM 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.
• Receives and maintains a copy of relevant correspondence related to JHU sponsor-investigators including applicable monitoring reports.
• Administratively coordinates the IND-IDE Review Committee by scheduling meetings, creating agendas, developing meeting minutes, and other administrative support activities as needed.

Other Duties

• Manages non-program-specific regulatory projects as requested by the Director, OCT.
• 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 stakeholders.
• 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.
• This position does not require the supervision of others at this time, however, as the regulatory program expands, there will be opportunities for supervisory responsibilities in the future.

*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.

• Master's Degree in health-related sciences.
• Minimum of 3 years of professional experience in regulatory/compliance function 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 subject's 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.

Licensure, Certification, Registration

• Regulatory Affairs and/or Clinical Research Professional Certification preferred (RAC, CCRP/SOCRA).
  

• Advanced Certificate in Clinical Trial Management.

Special Knowledge, Skills, or Abilities / Competencies

• Must have and exhibit computer skills (Microsoft Office, Access Database) 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.
  

Physical Requirements

• 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 
Job Posting Title (Working Title): IND/IDE Program Director   
Role/Level/Range: ATP/04/PF  
Starting Salary Range: $85,000 - $149,800 Annually ($85,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F/37.5 
Exempt Status: Exempt 
Location: Remote 
Department name: SOM Admin Res Clinical Research Contract 
Personnel area: School of Medicine