Summary

The Senior Manager, Regulatory Affairs will serve as the inaugural leader of Protocol Development (PD) within the Center for Research Advancement (CRA) and will be responsible for management and oversight of Investigator-Initiated Protocols, Investigational New Drug Studies (IND), and Investigational New Device Studies (IDE) in the Department of Pediatrics, and various divisions within the Texas Children’s Hospital Enterprise. This position will be responsible for shepherding therapies and other biomedical technologies through all phases of protocol and product development life cycle. Will also provide leadership, strategic development, and IND/IDE regulatory oversight including analysis, interpretation and implementation of institutional, local, state, and federal regulations, to provide guidance to Investigators/Study Teams.  Supports Protocol Development and IND studies in Pediatrics. Reporting structure through Medical Director & Executive Director of the Center for Research Advancement.

This position is eligible for future potential hybrid work schedule.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties

• Establish and manage the newly designated Protocol Development and Investigational New Drug Studies (IND) program in the Center for Research Advancement, and lead the support infrastructure for Department Faculty to develop investigator-initiated protocols and successfully submit grant and FDA submissions.
• Protocol Development/Submissions
  • Successful submission/management of protocol development life-cycle from inception to implementation of clinical research study/clinical trial -Interpret regulatory guidelines for investigators/stakeholders and provide potential regulatory submission strategies for the proposed project.
  • Evaluate and analyze the impact on new regulations and determine how to implement within the unit.
  • Apply knowledge of international, federal, state and local regulations as well as university and hospital policies to ensure optimal compliance.
  • Lead the preparation for pre-IND and pre-submission meetings and serve as the point of contact for FDA interactions/correspondence.
  • Plan and implement regulatory submissions (initial submission, amendment submissions and annual reports) in collaboration with the Regulatory Section of the CRA.
  • Oversee the submissions of reportable events to FDA, IRB and other regulatory authorities (as applicable).
  • Collaborate on development of manufacturing plans and product brochures/instructions of use.
  • Manage successful submissions of compassionate use IND protocols to FDA
• Perform other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Five years of relevant experience.

Preferred Qualifications

• Advanced degree in scientific or health related field.
• Extensive experience with Regulatory Guidelines and Food & Drug Administration collaborations.
• Requires good communication, interpersonal skills, and organization.
• Must have extensive experience with Regulatory Guidelines and FDA collaborations related to successful IND submissions.