Senior Manager, Clinical Diagnostics CDx (Precision Medicine)

About the role

You will support end-to-end CDx strategy and execution to enable therapeutics across indications. Partnering with biomarker, clinical, regulatory, commercial, and IVD collaborators, you will translate scientific needs into fit-for-purpose assays for global decisions. You will own programs from feasibility through analytical/clinical validation, registration, launch, and post-market sustainment, ensuring timelines, quality, and budgets aligned to drug milestones.

Responsibilities

• Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines for seamless program delivery.
• Lead cross-functional teams; integrate workstreams, clear obstacles, and provide transparent, regular status reporting to governance bodies and senior leadership.
• Manage IVD partners, negotiate scope, timelines, budgets, and quality; oversee co-development, Joint Steering Committees, and performance.
• Define assay intent and contribute to target product profiles (TPP) for CDx platforms (e.g., 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 with clinical teams, screening/stratification, sampling, site readiness, and lab operations for reliable execution.
• Partner with IVD Regulatory on global submissions, FDA PMA/supplements, 510(k) as applicable, EU IVDR, PMDA; support pre-subs, labeling, and responses.
• Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP; maintain documentation, audit readiness, and proactive, integrated risk management.
• Oversee design transfer, manufacturing readiness, and supply; support launch readiness with Commercial/Medical teams.

Requirements

• 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; successful validation and regulatory submissions.
• Expertise in NGS, PCR, IHC, immunoassays; validation standards and robust quality systems.
• Strategic thinking with the ability to translate scientific and clinical needs into executable diagnostic solutions.
• Strong grasp of global FDA CDRH, EU IVDR, PMDA pathways for CDx labeling.
• Excellent communication, leadership, and stakeholder management; clear, concise updates to executive audiences.
• Strategic translation of scientific and clinical needs into executable diagnostics under QMS/GxP.

Qualifications

• Travel up to 5-10% for partner meetings, clinical site visits, and regulatory interactions.

Skills

• Thrive in a fast-paced environment.
• Detail oriented, well-organized, and able to multi-task.
• Team player.
• Strong communication skills.