Senior Director, Oncology Clinical Trial Operations

Overview

Senior Director, Oncology Clinical Trial Operations

The Senior Director, Oncology Clinical Trials will lead the strategic planning and operational execution of oncology clinical trials evaluating Natera’s oncology products, with primary focus on Natera Sponsored interventional studies. Additional oncology portfolio support may be added over time. This role is responsible for feasibility assessment, enrollment modeling, timeline forecasting, budget development, and end-to-end study execution. The position requires a strong program management leader who can build scalable operational frameworks, manage CRO partnerships, lead cross-functional teams, and ensure high-quality data generation to support clinical utility, regulatory, and commercial objectives.

This individual will serve as a key operational partner across Clinical Development, Regulatory, Medical Affairs, Biostatistics, Oncology Product, and Commercial functions to ensure studies are executed efficiently, predictably, and with operational rigor.

• Lead and oversee the operational execution of oncology clinical trials designed to establish clinical validity, clinical utility, support regulatory submissions (PMA, 510(k), CE Mark), and generate data suitable for publication in high-impact peer-reviewed journals.
• Evaluate study concepts for feasibility, including enrollment projections, site landscape analysis, country strategy, and operational complexity.
• Establish enrollment models and predictive analytics to support milestone delivery.
• Lead CRO selection, scope development, and ongoing operational oversight.
• Establish performance metrics and ensure accountability to timelines, budget, and quality standards.
• Implement and oversee alternative sourcing models including FSP and staff augmentation when appropriate.
• Develop site selection and activation strategies to optimize enrollment velocity.
• Oversee laboratory readiness and performance for oncology trials, including tracking and analyzing key metrics (samples received, tests not performed, failure/repeat rates, specimen quality, and turnaround times) and apply in-depth knowledge of the Signatera assay and laboratory processes to mitigate operational risks and ensure data integrity.
• Ensure GCP compliance and inspection readiness.
• Manage clinical trial budgets and track progress (actuals) against forecast budget.
• Select, onboard and manage CROs, vendors, including building strong partnerships and establish governance structures and strong communication lines.
• Manage the hiring, training and oversight of Study Leaders, CRAs, CTAs and provide guidance on site issues.
• Work directly with Principal Investigators to solve problems and accelerate enrollment.
• Oversee development of enrollment documents including informed consent forms, clinical trial outlines, monitoring plans, synopses, IRB study protocols and amendments, clinical summaries, as-required binders, and electronic data capture projects.
• Coordinate review of data and preparation of interim/final clinical study reports.
• Develop SOPs, playbooks, and governance models that standardize program execution.
• Facilitate the personal development of staff, including fostering career growth, and providing relevant company-specific, ethical, and regulatory trainings.
• Assure a climate of equal employment opportunity and promote an equitable workplace.

• Degree in relevant scientific discipline or related field; advanced degree preferred (MS, Pharm
  
  D, MD, or PhD).
• >10 years of clinical research experience, including at least 5+ years of experience in managing clinical trials as a leading role.
• Significant global CRO leadership experience, including development of governance frameworks and enterprise-level oversight models.
• Experience managing all aspects of clinical trials separately, including study design, protocol implementation, site monitoring, and recruitment site management.
• Extensive experience overseeing oncology clinical trial programs is required.
• Knowledge and understanding of FDA and/or EMEA Regulations, and GCPs governing the conduct of clinical trials is required.
• The successful candidate must be able and willing…