Director overseeing hospice clinical services at Independent Living Systems, ensuring compliance and enhancing member outcomes through collaborative leadership.
About the role
- Associate Director leading clinical diagnostics strategy and development for Regeneron, focusing on companion diagnostic solutions aligned with drug approvals. Collaborating across teams while ensuring regulatory compliance.
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)
Requirements
- 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
- 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
Benefits
- Health and wellness programs (including medical, dental, vision, life, and disability insurance)
- Fitness centers
- 401(k) company match
- Family support benefits
- Equity awards
- Annual bonuses
- Paid time off
- Paid leaves (e.g., military and parental leave)
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