Associate Director, Clinical Diagnostics
2 days ago
Armonk
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. A typical day might include: • 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). This role might be for you if: • Proven track record delivering CDx aligned to drug approvals, including successful analytical/clinical validation and regulatory submissions., • Deep understanding of diagnostic platforms (NGS, PCR, IHC, Immunoassays) and associated validation standards and quality systems., • Experience managing external IVD partners and complex, cross-functional programs., • Strong knowledge of global regulations (FDA CDRH, EU IVDR, PMDA) and pathways for CDx approval and labeling., • Excellent communication, leadership, and stakeholder management skills., • Strategic thinking with the ability to translate scientific and clinical needs into executable diagnostic solutions., • Program leadership, planning, and risk management across multiple, fast-paced workstreams. To be considered for this position, you must have: • Advanced degree in a relevant field (e.g., MS/PhD in molecular biology, pathology, biomedical engineering, or related) or equivalent experience., • 8+ years of experience in diagnostics development, with 4+ years leading CDx or IVD programs in pharmaceutical or diagnostics settings Travel: Travel up to 510% for partner meetings, clinical site visits, and regulatory interactions.