Associate Director, Clinical Science

Natera
•$172,100 - $215,150•Remote

About The Position

Natera is hiring an Associate Director, Clinical Scientist in Oncology to execute clinical development strategies for its early cancer detection and cell-free DNA (cfDNA) In Vitro Diagnostic (IVD) portfolio. The role drives the design and execution of rigorous clinical studies, with responsibility for study activities, clinical strategy, and timely delivery of high-quality data that can impact patient care. The position develops and oversees clinical research plans for company- and investigator-initiated studies, contributes to regulatory interactions and submissions, supports study execution and data review, and works across functions with senior leaders, investigators, CROs, Key Opinion Leaders, consortiums, and clinical sites. It also supports advisory boards, scientific presentations, SOP development, and compliance with HIPAA/PHI regulations and training requirements.

Requirements

  • Ph.D., RN, MS, or B.S. in a scientific field; an advanced degree is preferred.
  • 8–10+ years of clinical research experience, including 3–5+ years in a management role.
  • Experience with project management, clinical research execution, and scientific writing.
  • Deep knowledge of regulatory standards and Good Clinical Practices (GCP).
  • Analytical problem-solving skills and ability to use data to test assumptions and troubleshoot complex problems.
  • Clear oral and written communication skills and rigorous attention to detail.
  • Ability to work cross-functionally and advance clinical objectives across organizational boundaries.
  • Proficiency with Google Workspace and Microsoft Office suites.
  • Execution-focused leadership, a rigorous work ethic, and strong project management, organizational, and interpersonal skills.
  • Ability to apply business knowledge, make data-driven judgments, and escalate issues.
  • Strategic and flexible thinking to address ambiguous problems and deliver actionable solutions.

Nice To Haves

  • Advanced degree such as an MS, PharmD, MD, or PhD.
  • Experience in oncology and early cancer detection.
  • Experience with In Vitro Diagnostics (IVD).

Responsibilities

  • Develop study concepts, including study design, schedules of assessments, objectives and endpoints, and eligibility criteria.
  • Integrate stakeholder feedback, author protocols, and 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 IDE, IND, and NDA filings.
  • Provide protocol training and contribute to Case Report Form (CRF) design.
  • Ensure study manuals align with protocols and engage investigators in study design methodology.
  • Participate in pre-site selection discussions, site initiation visits, and investigator meetings.
  • Contribute to and oversee real-time clinical data reviews, including oversight of CROs when applicable.
  • Participate in the review and management of safety reports and submissions.
  • Support clinical study conduct, including trial registration, results reporting, and monitoring emerging clinical and safety data trends.
  • Consult on data management deliverables, clinical monitoring activities, interim analysis planning, and Data Safety Monitoring Board or Steering Committee meetings.
  • Represent clinical science in internal and external meetings.
  • Provide senior management with data-backed updates on clinical timelines and support outcome-driven decisions to meet program milestones.
  • Support advisory boards and deliver scientific presentations.
  • Drive clinical research plans for company- and investigator-initiated studies.
  • Partner with senior leaders across functions to optimize clinical development and strategic execution.
  • Build data-driven relationships with Key Opinion Leaders (KOLs), consortiums, and clinical sites.
  • Develop Standard Operating Procedures (SOPs) and analyze complex data.
  • Ensure compliance with HIPAA/PHI regulations and maintain required training.
  • Adapt to evolving clinical needs and take ownership of tasks that advance the work.

Benefits

  • Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.
  • Free testing for employees and their immediate families.
  • Fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401(k) benefits.
  • Commuter benefits.
  • Employee referral program.
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