Senior Director, Oncology Clinical Trial Operations

Описание вакансии

POSITION SUMMARY:

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.

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PRIMARY RESPONSIBILITIES:

●        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

QUALIFICATIONS:

●        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 to travel to clinical trials sites, at times with minimal advanced notice

KNOWLEDGE, SKILLS, AND ABILITIES:

●        Ability to thrive and flourish in an entrepreneurial company environment requiring “hands-on” leadership

●        Strong interpersonal skills and communication skills (both written and oral).

●        Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.

●        Attention to detail, highly organized, with personal initiative 

●        Excellent team building and management skills

●        Excellent communication, conflict resolution, and follow-through skills

●        Results and goal oriented with willingness to roll up sleeves to achieve goals

●        Physical and intellectual energy, a sense of urgency, and a strong work ethic

●        Creative, strategic, flexible, and able to think “out of the box.”

●        Proficient in MS Word, Excel, PowerPoint and clinical trial databases.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

●        The ability to use a computer, communicate by telephone and read printed material is required.

●        Duties may require working outside normal working hours (evenings and weekends) at times.

●        Travel is required (up to 25%)

Compensation & Total Rewards

This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of  hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work-life benefits

Compensation Range

$265,800—$332,200 USD

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.

WHAT WE OFFER

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.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:

• BBB announcement on job scams 
• FBI Cyber Crime resource page