Vice President, Clinical Development (Oncology & Molecular Diagnostics)

Key Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Pay

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. Remote USA $350,000—$430,000 USD