Director, CDx Development

📋 Description

• Lead the formulation and implementation of integrated Companion Diagnostic (CDx) strategies within clinical development programs, ensuring alignment with overall drug development goals and timelines.

• Initiate early collaboration with Translational Discovery and Research teams to grasp predictive hypotheses and biomarker strategies for pipeline programs.

• Collaborate with internal research teams and external vendors to create predictive assays when appropriate assays are not readily available.

• Establish and promote CDx strategies through internal governance bodies, ensuring timely alignment and endorsement.

• Work cross-functionally to define Diagnostic Target Product Profiles and identify the most suitable diagnostic platforms and CDx partners.

• Collaborate closely with Regulatory Affairs to aid in the preparation and submission of regulatory documentation (e.g., IDEs, PMAs) and to engage with global health authorities as required.

• Supervise CDx development activities to guarantee timely delivery of diagnostic kits for pharmaceutical registration and commercial launch.

• Maintain clear and proactive communication with cross-functional stakeholders regarding CDx program progress, risks, and mitigation strategies.

• Monitor and analyze emerging industry trends, technological advancements, and changing regulatory requirements related to In Vitro Diagnostics (IVDs) and companion diagnostics.

⛳️ Requirements

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

• Strong scientific and technical knowledge in clinical development, biomarker strategies, and regulatory requirements for IVD and CDx products.

• Practical experience with diagnostic platforms such as Next-Generation Sequencing (NGS), Immunohistochemistry (IHC), Fluorescence In Situ Hybridization (FISH), and related technologies.

• Proven track record of leading complex, cross-functional programs to successful completion on time and within budget.

• Strong analytical and strategic thinking abilities, capable of making data-driven decisions in ambiguous or complex situations and thinking at a portfolio level.

• Demonstrated capability to influence and align stakeholders across development and commercial organizations without direct authority.

• Excellent communication skills, able to clearly convey complex scientific and strategic concepts to both technical and non-technical audiences.

• Experience working effectively in a matrixed environment and leading cross-functional teams.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness