Senior Director, Clinical Diagnostics – Precision Medicine

This is a fully remote position, open to applicants in New York.

📋 Description

• Establish and direct the global companion diagnostics strategy across the complete therapeutic pipeline and all applicable technologies.

• Align diagnostic plans with clinical strategies, development goals and timelines, regulatory requirements, launch preparations, and patient identification necessities.

• Convert biomarker biology, mechanism-of-action theories, and clinical utility considerations into diagnostic target product profiles.

• Outline the assay selection and development strategy from feasibility through analytical and clinical validation, regulatory submission, and post-approval lifecycle management.

• Direct diagnostic strategies that facilitate patient selection, stratification, monitoring, and evidence generation.

• Manage relationships with external IVD sponsors, laboratories, and technology partners, including selection, contracting, governance, budget management, and issue resolution.

• Ensure operational readiness of CDx testing in clinical trials, encompassing study initiation, laboratory workflows, sample management, data transfer, and quality oversight.

• Develop the global CDx regulatory strategy in collaboration with Regulatory Affairs, addressing FDA, EU IVDR, PMDA, and other regional requirements.

• Act as a senior CDx subject matter expert and strategic consultant to program teams and leadership.

• Impact decisions across translational medicine, clinical development, regulatory affairs, biostatistics, clinical operations, commercial strategies, medical affairs, market access, quality assurance, and legal matters.

• Lead and nurture a team of diagnostic professionals.

⛳️ Requirements

• An advanced degree (PhD, MD, MD/PhD, or equivalent) in molecular biology, pathology, translational medicine, oncology, biomedical engineering, diagnostics, or a related scientific field.

• A minimum of 12 years of experience in companion diagnostics, IVD development, biomarker strategy, or translational medicine within pharmaceutical, biotech, or diagnostic sectors.

• Progressive leadership experience.

• Proven success in overseeing CDx or biomarker-enabled diagnostic strategies throughout clinical development, regulatory submission, and therapeutic approval processes.

• Extensive expertise in assay development, analytical and clinical validation, and clinical utility.

• Solid understanding of global CDx regulatory pathways, including FDA CDRH (PMA and supplemental submissions), EU IVDR, PMDA, performance studies, labeling, and post-approval obligations.

• Experience in managing external diagnostic partners, IVD sponsors, central laboratories, CROs, and technology vendors within complex, time-sensitive projects.

• Demonstrated leadership abilities, including mentoring talent, developing capabilities, and prioritizing tasks in a collaborative and accountable team environment.

🏝️ Benefits

• Annual bonuses or other incentive programs.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness initiatives.

• Access to fitness centers.

• Medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodations during the recruitment process when necessary.