Associate Director, Clinical Diagnostics

Role Summary

This role provides an exciting opportunity to lead projects across diverse therapeutic areas. As the Associate Director, Clinical Diagnostics (CDx), you will own the end-to-end strategy, development, and lifecycle management of companion diagnostic solutions that enable our therapeutics. This role drives cross-functional alignment across biomarker science, clinical development, regulatory, commercial, and external IVD partners to deliver fit-for-purpose assays that meet global regulatory requirements and support clinical decision-making. You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality diagnostics aligned with drug development milestones.

Responsibilities

• Set the global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines for the therapeutic.
• Lead selection and oversight of IVD partners; negotiate scopes, timelines, budgets, and quality expectations; manage co-development and governance.
• Define assay intent and target product profiles (TPP) for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays), ensuring analytical and clinical performance meets intended use.
• Partner with biomarker and clinical teams to integrate CDx into trial designs (screening, enrichment, stratification), including sample strategy and operational readiness.
• 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 IVD Regulatory, support global regulatory strategy and submissions for CDx (e.g., FDA PMA/supplement, 510(k) where applicable, EU IVDR, PMDA), including pre-submission interactions and labeling alignment.
• Ensure compliance with applicable standards and regulations (e.g., ISO 13485, ISO 14971, CLSI guidelines, IVDR, GCP alignment for diagnostic use in trials).
• Coordinate cross-functional working groups, remove program obstacles, and provide transparent status reporting to governance bodies.
• Oversee design transfer, manufacturing readiness, and supply planning with IVD partners to ensure clinical and commercial availability.
• Drive risk management and mitigation plans across technical, regulatory, operational, and commercial domains.
• Partner with commercial and medical affairs to shape CDx launch readiness (access, coverage, distribution, training, KOL engagement).

Qualifications

• Required: 8+ years of experience in diagnostics development, with 4+ years leading CDx or IVD programs in pharmaceutical or diagnostics settings.
• Preferred: Proven track record delivering CDx aligned to drug approvals, including successful analytical/clinical validation and regulatory submissions.
• Preferred: Deep understanding of diagnostic platforms (NGS, PCR, IHC, Immunoassays) and associated validation standards and quality systems.
• Preferred: Experience managing external IVD partners and complex, cross-functional programs.
• Preferred: Strong knowledge of global regulations (FDA CDRH, EU IVDR, PMDA) and pathways for CDx approval and labeling.
• Preferred: Excellent communication, leadership, and stakeholder management skills.
• Preferred: Strategic thinking with the ability to translate scientific and clinical needs into executable diagnostic solutions.
• Preferred: Program leadership, planning, and risk management across multiple, fast-paced workstreams.

Education

• Advanced degree in a relevant field (e.g., MS/PhD in molecular biology, pathology, biomedical engineering, or related) or equivalent experience.

Skills

• CDx development and lifecycle management
• Cross-functional program leadership
• External IVD partner management
• Regulatory strategy and submissions (FDA CDRH, EU IVDR, PMDA)
• Analytical and clinical validation design
• Trial design integration for CDx (screening, enrichment, stratification)
• TPP definition and assay specification
• Risk management and mitigation
• Operational readiness, supply planning, and design transfer

Additional Requirements

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