Executive Director/Vice President, Companion Diagnostics (CDx)

Tyra Biosciences, Inc. is seeking an Executive Director/Vice President, Companion Diagnostics (CDx) who will lead the strategic, scientific, clinical, regulatory, and operational development of companion diagnostics across the company's oncology and precision medicine portfolio. This individual will be responsible for establishing and executing CDx strategies that enable biomarker-driven patient selection, support regulatory approvals, and optimize patient outcomes.

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The successful candidate will serve as the cross-functional leader for diagnostic development activities, collaborating closely with Clinical Development, Translational Science, Regulatory Affairs, Biometrics, Medical Affairs, Commercial, and external diagnostic partners. The role requires deep expertise in companion diagnostic development, assay validation, biomarker strategies, regulatory requirements, and commercialization pathways.

Essential Functions and Responsibilities

• Develop and execute comprehensive CDx strategies aligned with drug development programs from early research through post-marketing lifecycle management.
• Define biomarker-driven patient selection approaches to support precision medicine initiatives.
• Assess diagnostic technologies and platforms to enable clinical and commercial implementation.
• Provide strategic recommendations regarding CDx opportunities, risks, timelines, and investment decisions.
• Lead development of in vitro diagnostic (IVD) assays including analytical validation, clinical validation, and fit-for-purpose assessments.
• Oversee assay transfers, technology selection, and validation activities with external laboratory and diagnostic partners.
• Ensure diagnostic readiness for clinical trials and regulatory submissions.
• Establish diagnostic development plans integrated with overall drug development timelines.
• Develop global regulatory strategies for companion diagnostics in collaboration with Regulatory Affairs.
• Support interactions with FDA, EMA, PMDA, and other global health authorities regarding CDx development programs.
• Lead preparation of diagnostic-related sections for INDs, BLAs, NDAs, PMAs, and other regulatory submissions.
• Monitor and interpret evolving diagnostic regulations and guidance.
• Partner with Clinical Development teams to design biomarker-driven clinical studies.
• Support protocol development, patient screening strategies, enrollment forecasting, and biomarker analyses.
• Ensure diagnostic components are incorporated effectively into clinical trial execution.
• Contribute to interpretation of clinical and biomarker data for development and regulatory decision-making.
• Identify, evaluate, and manage relationships with diagnostic companies, reference laboratories, CROs, and technology providers.
• Lead contract negotiations and governance activities with diagnostic partners.
• Monitor vendor performance, timelines, budgets, and deliverables.
• Serve as the internal subject matter expert on Companion Diagnostics and precision medicine strategies.
• Chair cross-functional working groups focused on biomarker and diagnostic development.
• Communicate CDx strategy and progress to senior leadership and governance committees.
• Mentor and develop scientific and operational team members.
• Collaborate with Commercial and Market Access teams on diagnostic adoption strategies.
• Assess diagnostic implementation requirements, reimbursement considerations, and testing accessibility.
• Support launch planning for CDx-enabled therapeutic products.

Education & Experience

• PhD, MD, PharmD, MS, or equivalent advanced degree in Molecular Biology, Genetics, Clinical Laboratory Science, Pathology, Biomedical Sciences, or related discipline.
• Advanced degree preferred.
• 12+ years of biotechnology, pharmaceutical, diagnostics, or precision medicine industry experience.
• 8+ years of direct experience in Companion Diagnostics, biomarker development, molecular diagnostics, or precision medicine.
• Demonstrated experience supporting CDx development for oncology or other biomarker-driven therapeutic programs.
• Experience managing diagnostic partnerships and external laboratories.
• Proven success supporting global regulatory submissions involving companion diagnostics. xhyhwjd
• Knowledge of FDA PMA, IVD regulations, IVDR, and global diagnostic regulatory requirements.