Senior Director, Regulatory Affairs - Companion Diagnostics (CDx)

The Opportunity:

The Global Head of Regulatory Affairs for Companion Diagnostics (CDx) will define and lead the end-to-end global regulatory diagnostic strategy for the company’s portfolio. This person will be accountable for the regulatory success of companion diagnostics supporting targeted therapies, ensuring synchronized drug–diagnostic co-development from discovery through global registration and launch. Ensure companion diagnostics are fully integrated into clinical development plans with no downstream regulatory surprises, that drug and CDx approvals are synchronized globally, enabling seamless registrational and commercial execution. Help make the company a leader in targeted oncology CDx development.

The role spans US, EU, and Asia-Pacific markets, with direct responsibility for aligning CDx development with clinical strategy, regulatory pathways, and commercialization plans. The successful candidate will operate as a strategic partner to Translational Sciences, Clinical Development, and Commercial partners.

Enterprise CDx Strategy & Leadership:

• Define and execute a global companion diagnostic regulatory strategy aligned with the company’s precision oncology pipeline and long-term portfolio vision.

• Ensure early and durable integration of biomarker and CDx strategies into clinical development programs from first-in-human through registration.

• Build and lead a high-performing global regulatory CDx organization, fostering a culture of scientific rigor, accountability, collaboration, and execution excellence.

• Own and manage the global regulatory CDx operating budget, ensuring efficient allocation of resources to maximize program value and regulatory success.

Global Regulatory Strategy & External Partnerships:

• Develop and direct global regulatory strategies for companion diagnostics, including:

  • FDA (PMA, sPMA, IDE, 21 CFR 809/812)

  • EU IVDR (Regulation (EU) 2017/746)

  • PMDA (Japan) and other key ex-US authorities

• Ensure alignment of therapeutic and diagnostic regulatory timelines, including coordinated NDA and CDx submissions across programs.

• Have input on the selection, governance, and performance management of diagnostic partners.

• Provide regulatory leadership on bridging strategies, analytical validation plans, and global testing approaches to support registrational claims and post-approval lifecycle management.

Commercial & Launch Readiness:

• Partner with Commercial, Market Access, and Medical Affairs teams to ensure successful global CDx launch readiness, including:

  • Labeling alignment

  • Reimbursement and access strategy

  • Testing infrastructure and adoption

Required Skills, Experience and Education:

• Advanced relevant technical degree in Molecular Biology, Pathology, Genetics, or a related discipline.

• 14+ years of experience in pharmaceutical, biotechnology, or diagnostics organizations, including 10+ years leading companion diagnostics or biomarker-driven programs.

• Demonstrated success leading FDA and global CDx regulatory submissions, including PMA/IDE and IVDR-related activities.

• Deep expertise in NGS and PCR technologies, biomarker validation, and clinical implementation in oncology.

• Proven ability to lead complex, matrixed organizations and drive alignment across scientific, clinical, regulatory, and commercial stakeholders.

Preferred Skills:

• Prior experience supporting registrational oncology trials with companion diagnostics.

• Track record of successful drug–diagnostic co-launches.

• Established external network with diagnostic manufacturers, CROs, and global regulators.

#LI-Hybrid #LI-JC1