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Company

The Johns Hopkins University · 6 hours ago

IND/IDE Program Director -115375

Maryland, United States

Full-time

Remote

Director/Executive

$85K/yr - $150K/yr

3+ years exp

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Hiring Manager

Dylan Grace

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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 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.

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.

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.

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.

Qualification

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IND/IDE regulationsFDA regulationsRegulatory complianceClinical research practicesRegulatory writingSOP developmentAudit experienceGLP knowledgeGMP knowledgeProject managementMicrosoft OfficeAccess DatabaseMedical terminology

Required

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.

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.