Vice President, Clinical Development (Oncology & Molecular Diagnostics)

Vice President, Clinical Development (Oncology & Molecular Diagnostics)

Reports to: Chief Medical Officer, Corporate

Location: United States (Remote, with up to 30% travel)

Position Summary

Natera is seeking a Vice President of Clinical Development to deliver absolute ownership over the strategy, design, and execution of Natera-sponsored clinical studies. This corporate leader will institutionalize clinical trial architecture across the enterprise, distinct from therapeutic area strategy, with an immediate focus on defending and expanding our oncology footprint (including Early Cancer Detection and Signatera MRD), alongside corporate-level support for Women's Health and Organ Health.

Reporting directly to the Chief Medical Officer, you will be accountable for the operational health, scientific validity, and clinical utility data generated by Natera’s multi-million dollar sponsored study portfolio. This is a high-autonomy role for a builder who can navigate rapid structural transitions—specifically our evolution from a Laboratory Developed Test (LDT) framework into highly regulated FDA In Vitro Diagnostic (IVD) and Companion Diagnostic (CDx) pharma partnerships.

Key Responsibilities

• Portfolio Architecture & Governance: Establish and enforce portfolio-level governance models to monitor study health, site enrollment, milestone delivery, sample flow, and data readiness. Make definitive, data-driven go/no-go decisions on trial modifications, accelerations, or terminations based on objective strategic value and execution feasibility.
• Clinical Utility Design: Lead cross-functional teams to design high-impact prospective, observational, and decision-impact trials. Translate clinical questions into protocols that explicitly isolate and prove clinical validity, analytical validity, and decision-impact endpoints to secure broad commercial payer coverage and medical guideline inclusion.
• Regulatory & CDx Alignment: Partner with Regulatory affairs to build clinical evidence strategies that support FDA pre-market approval (PMA), 510(k), and De Novo pathways. Lead intended-use claim strategy and protocols that support companion diagnostic (CDx) co-development with biopharma partners.
• Operational Study Health: Direct internal Clinical Operations and external CROs to eliminate bottlenecks in site activation, sample transit degradation, and query resolution. Implement fast, corrective action plans for under-performing sites or delayed protocols.
• Scientific Footprint & Influence: Maintain and build a direct, peer-to-peer scientific relationship with leading academic investigators, cooperative groups, and guideline panel members. Personally author and contribute to landmark peer-reviewed publications and abstract presentations at major oncology and diagnostic symposia.

Qualifications

• MD, MD/PhD, or PhD with equivalent oncology pivotal or registrational trial leadership experience.
• 18+ years of experience in clinical development, clinical research, or clinical evidence generation, including at least 10 years personally directing oncology clinical trials.
• Diagnostics-native fluency: deep, unassisted comfort discussing cell-free DNA (cfDNA), ctDNA dynamics, minimal residual disease (MRD), analytical vs. clinical validity, and decision-impact metrics.
• Demonstrated experience operating cross-functionally within a highly matrixed environment with direct authority over clinical portfolios.
• Proven track record of designing evidence strategies that directly influenced regulatory submissions, multi-site registries, or national coverage determinations (LCDs/payors).
• High tolerance for ambiguity and an active bias for action; comfortable making critical portfolio trade-offs with incomplete information.