Associate Director, Clinical Science

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $172.1k - $215.2k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Develop rigorous study concepts, including study design, assessments, objectives/endpoints, and eligibility criteria • Integrate stakeholder feedback and direct protocol authoring • Respond to health authority feedback using data • Support regulatory interactions and author clinical sections for correspondence and submissions, including 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 site selection, site initiation visits, and investigator meetings • Oversee real-time clinical data reviews and CROs when applicable • Review and manage safety reports and submissions • Support clinical studies, trial registration, results reporting, and monitoring of clinical and safety trends • Consult on data management, clinical monitoring, interim analyses, and Data Safety Monitoring Board or Steering Committee meetings • Represent clinical science in internal and external meetings • Deliver data-backed clinical timeline updates to senior management • Support advisory boards and deliver scientific presentations • Drive company and investigator-initiated clinical research plans • Partner with senior leaders across functions to optimize clinical development and strategic execution • Build strategic relationships with KOLs, consortiums, and clinical sites • Develop SOPs and analyze complex data • Ensure HIPAA/PHI compliance and maintain training requirements • Adapt to evolving clinical needs and take ownership of work that advances objectives

🎯 Requirements

• 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 • Proficiency with Google Workspace and Microsoft Office suites • Rigorous project management, organizational, and interpersonal skills • Compliance with HIPAA/PHI regulations and all training requirements

🏖️ Benefits

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

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