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Clinical Laboratory Director

3 months ago

Hayward, United States Avirmax, Inc. Full time

About Us: Avirmax Inc is a Bay area, California based gene therapy company who received an IND approval for clinical trials for drug against wetAMD and symptomatic PCV. We are committed to advancing healthcare through cutting-edge research and high-complexity testing for lab developed test (LDT). Our goal is to achieve CLIA certification and set a benchmark for excellence in laboratory services.

Job Overview: We are seeking a dynamic and experienced Clinical Laboratory Director to join our team. This role is crucial for the establishment, certification, and operation of our CLIA-certified lab. The ideal candidate will be a versatile professional with a strong background in clinical laboratory settings and a thorough understanding of CLIA regulations. You will be responsible for overseeing the development and implementation of the lab, ensuring compliance with all regulatory requirements, and leading various projects from inception to completion.

Key Responsibilities:

  • Lead the establishment and operationalization of the new clinical laboratory.
  • Oversee the CLIA certification process, ensuring all regulatory standards and requirements are met.
  • Develop and implement standard operating procedures (SOPs) for all lab activities.
  • Manage and coordinate clinical studies, including study design, execution, and analysis.
  • Ensure the lab maintains the highest standards of quality and accuracy in testing.
  • Train and supervise laboratory staff, ensuring adherence to best practices and regulatory guidelines.
  • Collaborate with cross-functional teams, including research, quality assurance, and regulatory affairs.
  • Maintain up-to-date knowledge of advancements in clinical laboratory science and relevant regulations.
  • Prepare and present reports on lab activities, study outcomes, and compliance status to senior management.
  • Perform multiple roles as needed, from hands-on testing to administrative tasks, during the lab’s initial phase.

Qualifications:

  • Doctoral degree (Ph.D., M.D., or equivalent) in a relevant scientific discipline.
  • Must possess Clinical Laboratory Director License
  • Minimum of 5 years of experience in a clinical laboratory setting, with a focus on CLIA-certified labs.
  • In-depth knowledge of CLIA regulations and certification processes.
  • Proven experience in clinical study design, execution, and analysis.
  • Strong leadership and project management skills.
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to adapt to a dynamic and fast-paced work environment.
  • Demonstrated problem-solving skills and attention to detail.

Preferred Qualifications:

  • Previous experience in starting or managing a new clinical laboratory.
  • Experience with regulatory submissions and inspections.
  • Knowledge of Good Clinical Laboratory Practices (GCLP).

What We Offer:

  • Competitive salary and benefits package.
  • Opportunity to play a pivotal role in the growth and success of a pioneering clinical laboratory.
  • Collaborative and supportive work environment.
  • Professional development and career advancement opportunities.

How to Apply: Interested candidates are invited to submit their resume and cover letter detailing their relevant experience and qualifications to HR@avirmax.com. Please include "Clinical Study Director Application" in the subject line of your email.


Avirmax Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.