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Natera

Natera - Vice President, Clinical Development (Oncology & Molecular Diagnostics)

Remote - US Remote$350k - $350k2d ago
RemoteVpNAPharmaceuticalsGenomicsPresidentClinical DirectorClinical TrialsProspectingPartnership DevelopmentGovernanceRegulatory Affairs

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Requirements

• 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. • The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. • $350,000—$430,000 USD • OUR OPPORTUNITY • OUR OPPORTUNITY • Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. • The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

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. • Portfolio Architecture & Governance: • 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. • Clinical Utility Design: • 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. • Regulatory & CDx Alignment: • 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. • Operational Study Health: • 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. • Scientific Footprint & Influence:

Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! • For more information, visit www.natera.com.

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