Senior Manager, Clinical Diagnostics CDx (Precision Medicine)

Responsibilities:
- Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines.
- Lead cross-functional teams; integrate workstreams, remove obstacles, and provide status reporting to governance and senior leadership.
- Manage IVD partners: negotiate scope/timelines/budgets/quality; oversee co-development and Joint Steering Committees.
- Define assay intent; contribute to TPPs for CDx platforms (NGS, PCR, IHC, immunoassays).
- Drive analytical validation (accuracy, precision, sensitivity, specificity, LoD, reproducibility) and clinical validation linking performance to benefit–risk.
- Embed CDx assays in trials: screening/stratification, sampling, site readiness, and lab operations.
- Partner with IVD Regulatory on global submissions (FDA PMA/supplements, 510(k), EU IVDR, PMDA), including pre-subs, labeling, and responses.
- Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP; maintain documentation, audit readiness, and integrated risk management.
- Oversee design transfer, manufacturing readiness, and supply; support launch readiness with Commercial/Medical teams.

Qualifications:
- Advanced degree in molecular biology, pathology, biomedical engineering, or equivalent experience.
- 4+ years in diagnostics development; 2+ years leading CDx/IVD in pharma or diagnostics organizations.
- Proven delivery of CDx aligned to drug approvals, including validation and regulatory submissions.
- Expertise in NGS, PCR, IHC, immunoassays; validation standards and robust quality systems.
- Strategic thinking; ability to translate scientific/clinical needs into executable diagnostics under QMS/GxP.
- Strong knowledge of global FDA CDRH, EU IVDR, and PMDA pathways for CDx labeling.
- Excellent communication, leadership, and stakeholder management.

Travel:
- Up to 5–10% for partner meetings, clinical site visits, and regulatory interactions.

Application instruction:
- Apply now.