Associate Director, Clinical Science

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
• Rigorous project management, organizational, and interpersonal skills.
• Apply an ownership mindset, using data to push for action, close gaps, and deliver clinical outcomes
• Demonstrate strategic and flexible thinking to untangle ambiguous problems and deliver actionable solutions