Director CDx Development in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director CDx Development in United States.

This role sits at the intersection of precision medicine, clinical development, and diagnostic innovation, driving the strategy and execution of companion diagnostics across global drug development programs. You will lead end-to-end CDx initiatives that ensure biomarkers and diagnostic tools are seamlessly integrated into clinical pipelines, supporting both regulatory success and commercial readiness. Working in a highly collaborative and science-driven environment, you will partner closely with research, clinical, regulatory, and external diagnostic partners. Your work will directly influence how targeted therapies are developed and delivered to patients. This is a high-impact leadership role requiring both strategic vision and hands-on scientific expertise. You will help shape diagnostic pathways that enable more accurate, personalized cancer treatment. The environment is fast-moving, cross-functional, and mission-driven, with a strong focus on innovation and patient outcomes.

• Lead the end-to-end strategy and execution of companion diagnostics (CDx) across clinical development programs, ensuring alignment with drug development objectives and timelines.
• Partner with Translational Discovery and Research teams to define biomarker strategies and advance predictive hypotheses for pipeline assets.
• Collaborate with internal teams and external IVD partners to develop, validate, and optimize diagnostic assays and platforms.
• Define diagnostic target product profiles and support selection of appropriate CDx technologies and development partners.
• Drive regulatory strategy in collaboration with Regulatory Affairs, supporting submissions such as IDEs, PMAs, and global health authority interactions.
• Oversee CDx development timelines to ensure timely delivery of diagnostic solutions supporting clinical trials and commercial launches.
• Communicate program progress, risks, and mitigation strategies to cross-functional stakeholders and leadership teams.

This role requires a PhD combined with at least 5+ years of industry experience in clinical biomarker development and companion diagnostics, with a strong track record of supporting drug and/or diagnostic approvals. Candidates should bring deep expertise in clinical development, biomarker strategy, and regulatory requirements for IVD and CDx products. Hands-on familiarity with diagnostic technologies such as NGS, IHC, and FISH is essential. You should have demonstrated success leading complex, cross-functional programs in matrixed environments, delivering results on time and within budget. Strong strategic and analytical thinking is required, with the ability to operate at both portfolio and detailed execution levels. Excellent communication and stakeholder management skills are critical, particularly the ability to influence without direct authority. Experience working across research, clinical, and commercial functions is highly valued.

• Annual salary range: 176,600 – 236,600 USD
• Annual bonus eligibility for non-commercial roles
• Equity participation through discretionary stock awards and employee stock purchase plan
• Comprehensive medical, dental, and vision insurance coverage
• 401(k) retirement savings plan
• Flexible spending and health savings accounts (FSA/HSA)
• Life insurance and wellness programs
• Paid time off and company holidays
• Inclusive and mission-driven culture focused on advancing patient care and precision medicine