Clinical Laboratory Director

BioSpace
US - Maine - Gray
October 29, 2024
Pharmaceutical

Job DetailsWhy join Freenome?

Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw.
To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages.

Cancer is relentless.
This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives.
Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it's just the beginning.

Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.

At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease.
This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.

Become a Freenomer

Do you have what it takes to be a Freenomer? A "Freenomer" is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients' lives.
Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what's possible, one breakthrough at a time.

About this opportunity:

At Freenome, we are seeking a Laboratory Director to help grow the Freenome Laboratory Operations team.
The ideal candidate has demonstrated success establishing quality and compliance for new diagnostic laboratories.
This person is responsible for establishing and driving our clinical laboratory strategy including ensuring adherence to all CLIA and CAP regulatory requirements.
You are passionate about building laboratory capability and infrastructure, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

The role reports to the Vice President, Laboratory Operations.

What you'll do:

Participate in strategic planning for current and future laboratory services
Core team member to establish necessary laboratory performance metrics to achieve and sustain outstanding quality and customer service
Ensure adherence to CLIA and CAP regulatory requirements and good laboratory practices
Serve as expert resource and exception complex, cross-functional operational issues
Coordinate, lead, mentor, and support process improvements within functional roles to drive effectiveness, efficiency, cost savings, and productivity
Troubleshoot technical problems, with the aid of technical staff, and ensure that remedial action is taken whenever test systems deviate from the laboratory's performance standards
Consult, draft, edit, review, and approve standard operating procedures (SOPs) required for the performance of diagnostic testing
Ensure all licensure for diagnostic testing is in place and testing is in compliance with state and local regulations
Partner with Commercial to ensure all product descriptions (electronic and paper) are correct and compliance with CLIA and CAP regulatory requirements
Serve as a resource in creation, validation, documentation, and approval of specimen pre-analytical, analytical, and post-analytical results
Prepare, participate, and perform inspections to maintain licensure and ensure quality service delivery
Serve as a resource in the selection of test methodology and take initiative to improve systems, processes, and procedures to drive quality in daily production
Champion Quality Control, Proficiency Testing, and Inventory program
Ability to frequently and accurately communicate with employees, customers, health care providers, partners, and vendors representing the company

Must haves:

Doctoral Degree in a Chemical, Physical, Biological, or Clinical Laboratory Science from an accredited institution
Current certification as Medical Technologist / Medical Laboratory Scientist or appropriate categorical certification through the American Society for Clinical Pathology, American Medical Technologists (AMT) or American Association of Bioanalysts (AAB)
5+ years post-certification experience reviewing and signing out clinical test reports
Natural collaborator able to inspire action in a matrix or cross-functional environment
Strong leadership promoting communication and collaboration and proactively aiding in problem resolution and improvement efforts
Excellent communicator able to communicate goals and translate regulatory, business, and technical understanding in practical actions for internal and external audiences
Demonstrated ability to manage multiple competing priorities and drive successful and timely completion

Benefits and additional information:

The US target range of our base salary for new hires is $223,125 - $340,000.
You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.
Please note that individual total compensation for this position will be determined at the Company's sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education.
We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.

Freenome is proud to be an equal-opportunity employer, and we value diversity.
Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

Family & Medical Leave Act (FMLA)
Equal Employment Opportunity (EEO)
Employee Polygraph Protection Act (EPPA)

• LI-Remote

Read the full job description and apply online on the recuiter's web-site

Clinical Laboratory Director