Director CDx Development

About the role

This role will turn data into practical insight that improves visibility, decision-making, and business performance. You will partner with business, technical, and operational stakeholders to build reporting, surface trends, and translate analysis into action. The position offers the opportunity to strengthen data-driven execution and help teams focus on the metrics that matter most within a life sciences environment.

Location: Remote – US based candidates only, no visa sponsorship available

Responsibilities

• Develop and execute integrated CDx strategies in alignment with drug development timelines
• Engage with research teams to clarify predictive hypotheses and biomarker strategies
• Collaborate with teams to develop assays when existing options are inadequate
• Define CDx strategies and secure governance body endorsement
• Work with regulatory teams on documentation and global health authority interactions
• Oversee CDx development activities for timely delivery of diagnostic kits
• Provide proactive communication on program progress, risks, and solutions
• Monitor industry trends and regulatory changes affecting IVDs and CDx

Qualifications

• PhD with 5+ years in clinical biomarker testing and companion diagnostics development
• Strong expertise in clinical development and regulatory requirements for IVD and CDx
• Hands-on experience with diagnostic technologies such as NGS and IHC
• Proven ability to lead cross-functional programs to successful completion
• Strong analytical skills for data-driven decision-making and strategic thinking
• Demonstrated capacity to influence stakeholders across organizations
• Excellent communication skills for diverse audiences
• Experience in a matrixed environment and leading teams

Benefits

• Comprehensive medical, dental, and vision coverage
• 401(k) retirement plan
• Flexible spending accounts (FSA/HSA)
• Life insurance
• Paid time off
• Wellness programs
• Participation in the annual bonus plan and stock options

Pay: $176,600 – $236,600 annually