Senior Manager, Clinical Diagnostics CDx (Precision Medicine)

Role Responsibilities:
- Execute end-to-end companion diagnostics (CDx) strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines.
- Lead cross-functional teams, integrate workstreams, clear obstacles, and provide transparent status reporting to governance bodies and senior leadership.
- Manage IVD partners, negotiating scope, timelines, budgets, and quality; oversee co-development and Joint Steering Committees.
- Define assay intent and contribute to target product profiles for CDx platforms (e.g., NGS, PCR, IHC, immunoassays), driving analytical and clinical validation.
- Embed CDx assays in trials (screening/stratification, sampling, site readiness, lab operations).
- Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), including pre-submissions, labeling, and responses.
- Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI, IVDR, GCP), maintaining documentation and audit readiness.

Qualifications/Requirements:
- Advanced degree in molecular biology, pathology, biomedical engineering, or equivalent experience.
- 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs in pharma or diagnostics organizations.
- Proven delivery of CDx aligned to drug approvals, with successful validation and regulatory submissions.
- Expertise in NGS, PCR, IHC, and immunoassays; validation standards and quality systems.
- Strong grasp of global regulatory pathways (FDA CDRH, EU IVDR, PMDA) for CDx labeling.
- Excellent communication, leadership, and stakeholder management skills.

Application Instructions:
- Apply now.