Full-Time

Director of Clinical Affairs

Medical Writer

Posted on 8/28/2024

Natera

Natera

1,001-5,000 employees

Genetic testing and diagnostics solutions provider

Biotechnology
Healthcare

Compensation Overview

$169.3k - $211.6kAnnually

Senior, Expert

Remote in USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Data Analysis
Requirements
  • Degree in life sciences, medicine, or a related field, PhD preferred
  • Minimum of 10 years of experience in clinical research or clinical affairs within the medical technology or pharmaceutical industry.
  • Hands-on experience writing and developing clinical study documentation, including protocols and clinical study reports.
  • Strong knowledge of GCP, regulatory requirements and scientific best practices.
  • Excellent communication and interpersonal skills.
  • Ability to work collaboratively in a cross-functional team environment.
  • Strong attention to detail and organizational skills.
Responsibilities
  • Collaborate with Regulatory to determine when a diagnostic protocol is necessary
  • Partner with Medical Affairs to define clinical endpoints and develop scientifically sound diagnostic protocols that support Natera collaborations with Pharma and Consortia sponsors
  • Work directly with clinical study sponsors to ensure alignment of diagnostic and clinical study protocol objectives and endpoints
  • Develop and write diagnostic protocols, ensuring the protocol complies with FDA, IVDR, and ISO20916 standards, as required
  • Prepare diagnostic protocol amendments as needed to address study changes, evolving clinical and regulatory requirements, and at the request of the study sponsor or Natera Product team
  • Advise Clinical Trial Services on implementation of the diagnostic protocol, including review of protocol deviations and monitoring findings
  • Prepare comprehensive clinical study reports and collaborate with Medical Affairs and Biostats on data analysis and interpretation
  • Coordinate with Regulatory Affairs to compile regulatory documentation, ensuring compliance with submission requirements
  • Stay updated on industry trends, regulatory changes, and advancements in diagnostic methodologies to inform protocol development
  • Performs other duties as assigned

Natera focuses on genetic testing and diagnostics, providing advanced solutions for cancer patients, transplant patients, and individuals assessing hereditary health risks. Their main technology is cell-free DNA (cfDNA) testing, which analyzes DNA fragments in the blood to detect minimal traces of cancer and assess organ health. Natera stands out by offering specialized tests like the Signatera ctDNA test and Panorama NIPT, along with genetic counseling services. The company's goal is to improve patient care and health outcomes through accurate genetic testing.

Company Stage

IPO

Total Funding

$149.9M

Headquarters

Austin, Texas

Founded

2004

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

10%
Simplify Jobs

Simplify's Take

What believers are saying

  • Increased adoption of liquid biopsy techniques boosts demand for Natera's cfDNA tests.
  • AI integration enhances accuracy and speed of Natera's cfDNA analysis.
  • Growing personalized medicine trend aligns with Natera's customized genetic tests.

What critics are saying

  • Hindenburg report accuses Natera of deceptive sales practices, risking legal challenges.
  • New Prospera Heart features may face slow adoption by healthcare providers.
  • Fetal RhD NIPT demand may drop post-RhIg shortage, affecting future sales.

What makes Natera unique

  • Natera's Signatera test offers personalized ctDNA analysis for cancer patients.
  • Prospera Heart test uses unique Donor Quantity Score for transplant rejection detection.
  • Panorama NIPT test is a leader in non-invasive prenatal testing with 2 million tests.

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Benefits

Flexible medical plans

Investment options

Time off

Workplace perks

INACTIVE