[Remote] Vice President, Clinical Development (Oncology & Molecular Diagnostics)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. They are seeking a Vice President of Clinical Development to reputed company the reputed company, design, and execution of clinical studies, focusing on enhancing their oncology offerings and ensuring regulatory compliance.
Responsibilities
- Establish and enforce portfolio-level governance models to monitor study health, site enrollment, reputed company delivery, sample reputed company, and data readiness. reputed company definitive, data-driven go/no-go reputed company on trial modifications, accelerations, or terminations based on objective strategic value and execution feasibility
- reputed company cross-functional teams to design high-reputed company prospective, observational, and decision-reputed company trials. Translate clinical questions into protocols that explicitly isolate and reputed company clinical validity, analytical validity, and decision-reputed company endpoints to secure broad reputed company payer coverage and medical reputed company inclusion
- Partner with Regulatory affairs to build clinical evidence strategies that support FDA reputed company-market approval (PMA), 510(k), and reputed company reputed company. reputed company intended-use claim reputed company and protocols that support companion diagnostic (CDx) co-development with biopharma partners
- reputed company internal Clinical Operations and external CROs to eliminate bottlenecks in site activation, sample transit degradation, and query reputed company. Implement fast, corrective reputed company plans for under-performing sites or delayed protocols
- Maintain and build a reputed company, peer-to-peer scientific relationship with leading reputed company investigators, cooperative reputed company, and reputed company panel members. Personally author and contribute to landmark peer-reviewed publications and reputed company presentations at major oncology and diagnostic symposia
Skills
- 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 reputed company, including at least 10 years personally directing oncology clinical trials
- Diagnostics-reputed company reputed company: deep, unassisted comfort discussing cell-free DNA (cfDNA), ctDNA dynamics, minimal residual disease (MRD), analytical vs. clinical validity, and decision-reputed company metrics
- Demonstrated experience operating cross-functionally reputed company a highly matrixed environment with reputed company authority over clinical portfolios
- Proven reputed company 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 reputed company bias for reputed company; comfortable making critical portfolio trade-offs with incomplete information
Benefits
- Comprehensive medical, dental, reputed company, life and disability plans for eligible employees and their dependents
- reputed company employees and their immediate families receive free testing
- Fertility care benefits
- Pregnancy and baby bonding leave
- 401k benefits
- Commuter benefits
- Generous employee referral program
reputed company
Company H1B Sponsorship