POSITION SUMMARY

Join Natera as the Associate Director, Clinical Scientist in Oncology. You will execute clinical development strategies for our early cancer detection and cell-free DNA (cfDNA) In Vitro Diagnostic (IVD) portfolio, driving the design and execution of rigorous clinical studies that directly impact patient care. Every sample represents a real person, and you will take ownership of study activities, clinical strategy, and the timely delivery of high-quality data.

PRIMARY RESPONSIBILITIES

Develop rigorous study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria
Integrate stakeholder feedback and direct protocol authoring; use data to respond to health authority feedback
Support regulatory interactions and author clinical sections for regulatory correspondence and submissions, including briefing documents, presentations, and Investigational Device Exemption (IDE), IND, and NDA filings
Provide protocol training and contribute directly to Case Report Form (CRF) design
Ensure study manuals align with the protocol and engage investigators directly in study design methodology to ensure alignment with research objectives
Actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to drive successful study execution
Contribute to and oversee real-time clinical data reviews, including the rigorous oversight of Contract Research Organizations (CROs) when applicable
Participate in the review and management of safety reports and submissions, treating quality as foundational
Support project teams with the conduct of clinical studies, including trials registration, results reporting, and the monitoring of emerging clinical and safety data trends
Consult on data management deliverables, clinical monitoring activities, interim analyses planning, and Data Safety Monitoring Board or Steering Committee meetings
Serve as a clinical science representative in internal and external meetings, pushing for clarity and action
Deliver unvarnished, data-backed updates on clinical timelines to senior management, pushing for clarity and outcome-driven decisions to meet program milestones
Support advisory boards and deliver direct, scientific presentations.
Drive clinical research plans, spanning company and investigator-initiated studies
Think team by partnering directly with senior leaders across functions to optimize clinical development and drive strategic execution without needing translation layers
Build data-driven, strategic relationships with Key Opinion Leaders (KOLs), consortiums, and clinical sites
Develop Standard Operating Procedures (SOPs) and analyze complex data.
Ensure strict compliance with HIPAA/PHI regulations and maintain all training requirements
Adapt to evolving clinical needs, taking ownership of tasks that move the work forward without waiting for a finished playbook

QUALIFICATIONS

Ph.D., RN, MS, or B.S. in a scientific field; advanced degree preferred (MS, PharmD, MD, or PhD)
8–10+ years of clinical research experience, including 3–5+ years in a management role
Experience in oncology and early cancer detection is highly preferred
Experience with project management, clinical research execution, and rigorous scientific writing
Experience with In Vitro Diagnostics (IVD) is a plus
Deep knowledge of regulatory standards and Good Clinical Practices (GCP) is required

KNOWLEDGE, SKILLS, AND ABILITIES

Think analytically, testing assumptions with data to troubleshoot and solve complex problems
Clear, direct oral and written communication skills with rigorous attention to detail
Think team by pulling cross-functional partners into the work, operating seamlessly across boundaries to advance clinical objectives
Proficiency with Google Workspace and Microsoft Office suites
Operate with pace and precision as the science, product surface, and business continue to evolve
Execution-focused leadership and a rigorous work ethic
Apply business knowledge, exercise data-driven judgment, and escalate issues without hesitation