Director CDx Development
$176,600–$236,600 year
RemoteUnited States
Job Summary
Lead the development and execution of integrated companion diagnostics (CDx) strategies across clinical programs, ensuring alignment with drug development objectives and timelines. Engage early with Translational Discovery teams to understand predictive hypotheses and biomarker strategies, then partner with internal research and external vendors to develop predictive assays. Define Diagnostic Target Product Profiles, collaborate cross-functionally to identify optimal platforms, and work closely with Regulatory Affairs to support preparation of submissions and interactions with global health authorities. Oversee CDx development activities to ensure on-time delivery of diagnostic kits for pharmaceutical registration and commercial launch, while providing clear, proactive communication on program progress, risks, and mitigation strategies to cross-functional stakeholders.
Required Qualifications
- PhD
- minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development
- demonstrated record of successful drug and/or IVD approvals
- Strong scientific and technical expertise in clinical development, biomarker strategies, and regulatory requirements for IVD and CDx products
- Hands-on knowledge of diagnostic platforms such as NGS, IHC, FISH, and related technologies
- Proven ability to lead complex, cross-functional programs to completion on time and within budget
- Strong analytical and strategic thinking skills, with the ability to make data-driven decisions in ambiguous or complex situations and to think at a portfolio level
- Demonstrated ability to influence and align stakeholders across development and commercial organizations without direct authority
- Excellent communication skills, with the ability to convey complex scientific and strategic concepts clearly to both technical and non-technical audiences
- Experience working effectively in a matrixed environment and leading cross-functional teams
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