Associate Director of Clinical Affairs

Organization
BioFire Diagnostics
Job Location
515 Colorow Way
Salt Lake City, UT 84108
Salary
DOE
Benefits

There’s a lot to love about working at BioFire. Here are the top 10 things our employees say that they like the most:

  1. Contributing to work that saves lives and makes the world a healthier place
  2. Schedules and benefits that emphasize a healthy work/life balance – including at least 4 weeks of paid time off each year!
  3. Exceptional health and wellness benefits with a generous 401k plan with no vesting period
  4. Great pay and annual discretionary bonuses
  5. Culture of appreciation and recognition
  1. Challenging work with career growth opportunities
  2. Great management who implement employee ideas and rewards hard work
  3. Opportunities to learn new things and gain new skills, including tuition reimbursement
  4. Fun company events
  5. Casual working environment that feels like a home away from home
Job Description

The Associate Director of Clinical Affairs, under the supervision of the Director of Clinical Affairs, is responsible for the supervision of Clinical Affairs department scientists in the conduct of clinical studies required to support regulatory submission of BioFire’s in vitro diagnostic products in compliance with US and foreign medical device/IVD regulations, ICH GCP, the Declaration of Helsinki and other applicable guidelines for human subjects protections, and in alignment with BioFire’s commercialization strategies. This includes strategy development, project planning, study design, protocol development, and resource management. In addition, the Associate Director of Clinical Affairs contributes to maintaining BioFire’s policies and procedures with respect to compliance to relevant regulatory requirements and ensuring that clinical studies are conducted in accordance with these policies.

Requirements

Requirements:

  1. This position requires excellent written and oral communication skills.
  2. Excellent interpersonal skills and the ability work with a wide variety of people (physicians, laboratory directors, laboratory staff , etc) involved in conducting the clinical studies.
  3. The ability to work closely with Director of Clinical Affairs to identify and communicate areas of technical, schedule, and budget risk.
  4. Excellent organizational skills are essential.
  5. Some driving within Salt Lake County may be required. Must provide own transportation.
  6. Domestic and international travel required – up to 20%


Training and Education:

Ph.D. in a relevant scientific field, or equivalent (such as Master’s degree with experience).

Experience:

At least 5 years conducting clinical studies for in vitro diagnostic products.

Skills:

Strong writing and communication skills.


BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires.  Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal.

About Our Organization

At BioFire, we make a difference, we make the world a healthier and better place. We provide molecular solutions that lessen the time to medical results, empower healthcare professionals to make better diagnostic decisions and lower healthcare costs. We are committed to improving the quality of life for everyone, everywhere, every day.

We surround ourselves with world-class individuals and are committed to a set of principles to build a thriving organization and foster a vibrant community based on trust, integrity and a shared sense of purpose. We reinforce each other’s discipline, creativity and sense of the possible in an exciting environment that is characterized by mutual respect and challenging and fulfilling activity. The diligent and interdependent work of every individual is what makes BioFire exceptional.

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