Title:  Director, Regulatory Affairs

Summary

The Director is responsible for the strategic direction, implementation, and management of the BCM Clinical Trials Support Office to support the qualification and registration of investigator-initiated trials. In addition, the IND/IDE Program Director will develop and maintain all operational functions that support IND/IDE activities and other clinical research initiatives with oversight by Research Support Services. This role provides institutional -wide leadership, industry standards, policies, and a common infrastructure for clinical trial conduct at BCM, and functions as a liaison between investigators, study teams, and other partners across the College in support of clinical research. The Director works to address questions of IND/IDE sponsors through the initial application process to the Food and Drug Administration (FDA) and follow-up correspondence, including amendments and reporting. Serves as the liaison between the Office of Research, internal partners, and external partners, including the FDA.

This position is eligible for an annual performance-based bonus.

Job Duties

• Directs the Clinical Research Initiatives Support Office (CRISO) team; defines work responsibilities and prioritization; sets performance development plans and goals; and conducts annual performance evaluations; oversees hiring activities and the department’s budget.
• Directs all components of the BCM sponsor-investigator qualification and suitability process.
• Responsible for the initial review of sponsor-investigator qualification submissions and IND/IDE suitability submissions.
• Develops strategic plans for research mission clinical research initiatives, including leading infrastructure and staffing initiatives; Incorporate long-range planning of the program's activities.
• Designs and delivers IND-IDE workshops, presentations, and other educational materials and opportunities; leverages external training to benefit the program and research activities; effectively communicates the program's objectives to appropriate stakeholders.
• Develops and reports on metrics and key performance indicators for the program; reports complex data to stakeholders.
• Provides support to address questions of BCM IND/IDE sponsors through the initial application process to the FDA and follow-up correspondence, including amendments and reporting.
• Evaluates and guide the development of sponsor-investigator SOPs and monitoring plans.
• Guides sponsor-investigator and study teams in developing their submissions to the FDA; guides monitoring teams and provides a review of ongoing monitoring reports; guides internal and external audits; prepares corrective actions as required.
• Develops, reviews, and maintains the program's policies and procedures.
• Develops, reviews, and maintains templates, tools, and guidance documents needed for the program's function; executes the program's website.
• Advances their current knowledge of the regulatory environment, especially regulations changes and guidance documents applicable to sponsor-investigator research.

Minimum Qualifications

• Bachelor’s degree.
• Eleven years of directly related experience with four years of supervisory experience.

Job Specific Criteria

• Knowledge of clinical research practices and principles is required.
• Ability to work independently and drive processes
• Ability to manage projects
• Ability to work in a team and demonstrated interpersonal skills
• 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 managing multiple and competing priorities
• Excellent customer service skills, including the ability to interact effectively with diverse stakeholders, including faculty, research staff, and the FDA

Preferred Qualifications

• Master’s degree. Seven years of directly related experience with four years of supervisory experience.
• Certification as a Certified Clinical Research Professional (CCRP) or Clinical Research Associate (CRA).
• Experience and functional knowledge of FDA regulations related to clinical research involving human participants.
• Well-versed in human subjects' research requirements and guidance according 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 environments.
• Prefer experience in regulatory writing and regulatory submission work.
• 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.