Associate Director, Clinical Diagnostics

About the role

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.

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.
• Collaborate 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.

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.

Qualifications

• 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.

Skills

• Strong leadership and project management skills.
• Excellent communication and collaboration abilities.
• Knowledge of regulatory processes and standards.
• Ability to work effectively in a cross-functional team environment.
• Experience with biomarker science and clinical development.

Benefits

• Comprehensive health and wellness programs.
• Flexible work schedule (4 days per week on-site).
• Competitive compensation and benefits package.
• Equity awards and pension or retirement benefits.
• 401(k) company match.
• Family support benefits.

Pay

$176,100.00 - $287,300.00 annually

Schedule

Hybrid: 4 days per week on site