IND
IND (Investigational New Drug) is a key step in getting new medicines approved for use. It's like a permission slip that pharmaceutical companies need to get from the FDA before they can test new drugs on humans. When you see "IND" in job descriptions, it usually means the role involves helping prepare or manage these important applications that allow companies to start clinical trials. Think of it as the paperwork and planning stage that happens before a new medicine can be tested on people.
Examples in Resumes
Managed documentation and submissions for 12 IND applications to FDA
Led cross-functional teams in preparation of IND filings
Successfully coordinated multiple IND submissions resulting in FDA clearance
Provided regulatory strategy support for Investigational New Drug applications
Typical job title: "IND Managers"
Also try searching for:
Where to Find IND Managers
Professional Organizations
Job Boards
Professional Networks
Example Interview Questions
Senior Level Questions
Q: How would you handle a situation where the FDA has placed a clinical hold on an IND?
Expected Answer: The candidate should explain the process of addressing FDA concerns, including organizing response teams, reviewing safety data, preparing response documentation, and maintaining communication with stakeholders.
Q: Describe your experience with developing regulatory strategies for complex IND submissions.
Expected Answer: Look for answers that demonstrate leadership in planning submission timelines, coordinating with different departments, and understanding how to address challenging regulatory requirements.
Mid Level Questions
Q: What key components must be included in an IND application?
Expected Answer: Should be able to list main sections like pre-clinical data, manufacturing information, clinical protocols, and investigator information, explaining them in simple terms.
Q: How do you ensure quality control in IND submissions?
Expected Answer: Should discuss document review processes, quality checkpoints, and coordination with various teams to ensure accuracy and completeness.
Junior Level Questions
Q: What is the purpose of an IND?
Expected Answer: Should explain that it's the FDA application required to start testing new drugs in humans, demonstrating basic understanding of the drug development process.
Q: What are the different types of IND applications?
Expected Answer: Should be able to describe commercial and research INDs, and explain their basic differences in simple terms.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of FDA regulations
- Document organization and filing
- Team coordination
- Basic regulatory writing
Mid (2-5 years)
- IND application preparation
- FDA communication management
- Cross-functional team coordination
- Regulatory submission planning
Senior (5+ years)
- Strategic regulatory planning
- Complex submission management
- FDA meeting leadership
- Team mentoring and development
Red Flags to Watch For
- No knowledge of basic FDA regulations
- Lack of attention to detail in documentation
- Poor understanding of clinical trial processes
- No experience with regulatory submissions
- Inability to explain regulatory requirements in simple terms
