Vice President, Clinical Development – Oncology, Molecular Diagnostics

🕒 il y a 3 jours

🇺🇸 États-Unis – Télétravail

💵 $350 000 - $430 000 / an

⏰ Temps Plein

🔴 Expert

👔 Vice-président

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Natera

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 2004

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

Biotechnology • Healthcare Insurance • Pharmaceuticals

Natera est un leader mondial de la technologie de tests d'ADN libre circulant, spécialisé dans les tests génétiques non invasifs et les diagnostics. Les solutions innovantes de l'entreprise se concentrent sur des domaines tels que le dépistage prénatal, la détection du cancer et la surveillance des greffes d'organes. En utilisant une bioinformatique avancée et une analyse de l'ADN, Natera fournit aux professionnels de la santé et aux patients des informations cruciales pour prendre des décisions médicales plus éclairées.

Description

• Deliver absolute ownership over the strategy, design, and execution of Natera-sponsored clinical studies. • Establish and enforce portfolio-level governance models to monitor study health, site enrollment, milestone delivery, sample flow, and data readiness. • Lead cross-functional teams to design high-impact prospective, observational, and decision-impact trials. • Partner with Regulatory affairs to build clinical evidence strategies that support FDA pre-market approval (PMA), 510(k), and De Novo pathways. • Direct internal Clinical Operations and external CROs to eliminate bottlenecks in site activation, sample transit degradation, and query resolution. • Maintain and build a direct, peer-to-peer scientific relationship with leading academic investigators, cooperative groups, and guideline panel members.

🎯 Exigences

• 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.

🏖️ Avantages

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. • Free testing for Natera employees and their immediate families in addition to fertility care benefits. • Pregnancy and baby bonding leave. • 401k benefits. • Commuter benefits. • Generous employee referral program!