Director, CDx Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the formulation and implementation of integrated Companion Diagnostic (CDx) strategies throughout clinical development programs, ensuring they align with comprehensive drug development goals and timelines.

• Initiate early collaboration with Translational Discovery and Research teams to gain insights into predictive hypotheses and biomarker strategies for pipeline initiatives.

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

• Outline and progress CDx strategies through internal governance entities, ensuring timely alignment and approval.

• Work in partnership with cross-functional teams to establish Diagnostic Target Product Profiles and pinpoint the best diagnostic platforms and CDx collaborators.

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

• Supervise CDx development tasks to guarantee the timely delivery of diagnostic kits that support pharmaceutical registration and market launch.

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

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

⛳️ Requirements

• PhD with at least 5+ years of experience in the industry focusing on clinical biomarker testing and the development of companion diagnostics.

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

• Practical expertise in diagnostic platforms including NGS, IHC, FISH, and related technologies.

• Proven track record of successfully leading complex, cross-functional projects to completion on schedule and within budget.

• Strong analytical and strategic thinking capabilities, with the ability to make data-driven decisions in uncertain or complex scenarios and to consider portfolio-level impacts.

• Demonstrated capacity to influence and align stakeholders across development and commercial sectors without direct authority.

• Exceptional communication skills, capable of articulating intricate scientific and strategic ideas clearly to both technical and non-technical audiences.

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

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness