Director, Companion Diagnostics

Position Summary

The Director for Companion Diagnostics will drive cross-functional alignment of biomarker operations, clinical development, regulatory & quality expectations with external device & In vitro diagnostic (IVD) partners to deliver fit-for-purpose devices that meet global regulatory requirements and support clinical decision-making. This individual will serve as a key partner to cross-functional teams leading CDx development through IVD clinical validation & requirements for registration, approval, and launch ensuring timely availability of high-quality devices and IVDs aligned with drug development milestones.

Key Responsibilities

• Aligning IVD & clinical milestones with IVD quality & regulatory expectations to the timelines for the therapeutic.
• Lead oversight of device and IVD partners, ensure alignment to scopes of work, timelines, budgets, and quality expectations; manage co-development and governance.
• Define device and IVD intent, user needs, and target product profiles for CDx platforms (e.g., NGS, PCR, IHC, software, DHTs, etc.) ensuring IVD analytical and clinical performance meets intended use.
• Partner with biomarker and clinical teams to ensure IVD integration into interventional clinical studies (e.g., screening, enrichment, stratification, etc.) including alignment to sample strategy and operational readiness for device and IVD submissions.
• Drive analytical validation plans (e.g., accuracy, precision, sensitivity/specificity, LoD, reproducibility) and clinical validation strategies linking assay results to drug safety and efficacy.
• In collaboration with diagnostic and device partners, support global regulatory strategy and submissions (e.g., FDA PMA, 510(k), EU IVDR, PMDA) including pre-submission interactions and labeling alignment.
• Ensure compliance with applicable device standards and regulations (e.g., ISO 13485, ISO 14971, CLSI guidelines, QMSR, IVDR, GCP alignment for diagnostic and device use in clinical trials, etc.)
• Coordinate cross-functional working groups, conduct audit preparedness (e.g., device and IVD BIMO, PAI, etc.), remove program obstacles, and provide transparent status to governance bodies.
• Oversee document review and coordinate cross-functional team's recommended edits, IVD partner audit preparedness & manufacturing readiness, and supply planning with diagnostic and device partners to ensure timely clinical and commercial availability.

Qualifications

• Advanced degree in relevant field (e.g., molecular biology, biomedical engineering, or related) or equivalent experience. RAC preferred.
• 10+ years of experience in diagnostic development, with 4+ years leading CDx or IVD programs in pharmaceutical, medical device, or diagnostic settings.
• Proven track record delivering CDx aligned to drug approvals, including successful analytical/clinical validation and device regulatory requirements. Experience preferred in rare disease and oncology indications.
• Deep understanding of diagnostic platforms (NGS, PCR, IHC, software, DHTs, etc.) and their associated verification and validation device standards and quality systems.
• Experience managing external IVD partners and complex, cross-functional programs.
• Awareness of evolving regulatory and quality expectations and ability to translate into actionable guidance.