Director CDx Development

About the role

The Companion Diagnostics (CDx) Lead will be responsible for defining and executing end-to-end diagnostic strategies that are fully aligned with clinical development programs and timelines. This role partners closely with research, clinical, regulatory, and commercial teams, as well as external IVD collaborators, to ensure the successful development, regulatory approval, and launch of companion diagnostics that enable precision medicine.

Essential Functions Of The Job

• Lead the development and execution of integrated CDx strategies across clinical development programs, ensuring alignment with overall drug development objectives and timelines.
• Engage early with Translational Discovery and Research teams to understand predictive hypotheses and biomarker strategies for pipeline programs.
• Persistently collaborate cross-functionally to define Diagnostic Target Product Profiles and identify optimal diagnostic platforms and CDx partners.
• Collaborate closely with Regulatory Affairs to support the preparation and submission of regulatory documentation (e.g., IDEs, PMAs) and to interact with global health authorities as needed.
• Oversee CDx development activities to ensure on-time delivery of diagnostic kits to support pharmaceutical registration and commercial launch.
• Provide clear, proactive communication to cross-functional stakeholders on CDx program progress, risks, and mitigation strategies.
• Maintain awareness of emerging industry trends, technology advancements, and evolving regulatory requirements related to IVDs and companion diagnostics.

Requirements

• PhD with a minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development, with a 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.

Supervisory Responsibilities

Contribute to broader training, leadership, and management activities as required.

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Pay

Salary Range: $176,600.00 - $236,600.00 annually

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness