POSITION SUMMARY:

The Director of Clinical Affairs is a hands-on technical leadership role focused on the strategic planning, development, and analysis of clinical trials where Natera collaborates with Pharma and Consortia groups to provide diagnostic testing. This position involves close collaboration with Clinical Trial Services, Medical Affairs, Regulatory, and Biostats to ensure the successful design and reporting of diagnostic trials (clinical performance studies). The Director will be responsible for framing and writing critical study documentation, including diagnostic protocols and clinical study reports. As a member of the Clinical Trials leadership team, the Director will contribute to the strategic direction and operational excellence of the company’s clinical research initiatives supporting the Clinical Trial department mission-- to drive evidence generation leading to new product development, changing clinical guidelines, and securing reimbursement by running compliant and cost-effective clinical studies.

PRIMARY 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

QUALIFICATIONS:

• 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.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Technical: Strong understanding of clinical trial design, regulatory requirements, and protocol development.
• Behavioral: Excellent problem-solving skills, ability to work under pressure, strong leadership and mentorship capabilities, effective communication, and collaboration skills

PHYSICAL DEMANDS & WORK ENVIRONMENT:

Duties are typically performed in an office setting. This position requires the ability to use a computer keyboard, communicate over the telephone, and read printed material. Duties may require working outside normal working hours (evenings and weekends) at times.