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Team Leadership
Role Overview:
- Provide strategic regulatory leadership for companion diagnostics (CDx), IVD, and precision medicine programs globally.
- Guide pharmaceutical, biotechnology, and diagnostic organizations through complex regulatory pathways from early development to commercialization.
- Translate scientific and clinical complexities into actionable development plans accelerating patient access.
Key Accountabilities:
- Lead strategic consulting engagements, develop integrated CDx regulatory strategies aligned with therapeutic goals and timelines.
- Prepare and review regulatory documentation, including FDA Q-Submissions, Pre-IDE, IDE, PMA, and international submissions.
- Support regulatory authority interactions and identify new consulting opportunities through client networks.
Candidate Profile:
- 7+ years of experience in IVD, companion diagnostics, or regulatory consulting environments.
- Minimum 5 years of direct consulting experience focusing on CDx or precision medicine programs.
- Strong understanding of FDA, EU IVDR, and global regulatory frameworks for diagnostic development.
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