Careers
Great people form the core of any great organization. PreludeDx is always looking for highly qualified people with a passion for improving the lives of cancer patients. We will periodically post information about openings but are always interested in hearing from those who believe in our mission and values.
For more information, contact: careers@preludedx.com
Open Positions
Job Title: Customer Care Reporting Specialist
Department: Customer Care
Reports To: Customer Care Reporting Manager
Location: Laguna Hills, CA (onsite)
Hours: M-F, 8:30am-5:30pm
Hourly Rate: $20-26 DOE
JOB PURPOSE
The Customer Care Reporting Specialist key objectives are to ensure accurate and timely processing and communication of laboratory test results, managing reporting workflows, and resolving exceptions that may impact turnaround time or data integrity. This role serves as a key liaison between internal laboratory teams and external clients, ensuring a high level of service, responsiveness and operational efficiency.
ESSENTIAL RESPONSIBILITIES
- Monitor daily reporting queues to ensure timely processing and release of laboratory results
- Verify completeness and accuracy of reports prior to distribution
- Coordinate with internal pathologists to resolve missing or incomplete scoresheets
- Track and communicate turn-around time and report status updates to clients and stakeholders
- Follow up and resolve report hold cases to keep turn-around-time within expected calendar days
- Responsible for faxing and emailing patient reports in a timely manner
- Identify, investigate and resolve reporting exceptions (e.g., additional specimen request, data discrepancies, delayed results)
- Communicate QNS cases to clients/sales prior to releasing QNS reports
- Request additional material for cases that present insufficient tumor
- Document all exceptions and resolutions in internal systems
- Filing as required
- Maintain strong relationships with clients through responsive and solution-oriented communication
- Maintain an organized work area
- May require occasional overtime based on workload or reporting deadlines
The above list represents the general duties considered essential functions of the job and is not to be considered an exhaustive description of all the work requirements that may be inherent in the position.
EXPERIENCE AND QUALIFICATIONS
- Lab experience preferred
- Associates/Bachelor’s degree a plus
- Working knowledge of MS Office
- Excellent typing and data entry skills
- High level of accuracy and attention to detail
- Work cross-functionally with accessioning, customer care, laboratory staff, logistics, sales/marketing and management teams
- Ability to adapt to changing procedures, policies and work priorities
- Ability to manage time-sensitive tasks in a fast-paced, team environment
- Ability to communicate effectively and follow written and verbal instructions
ABOUT PRELUDEDX
PreludeDx is an Innovative Healthcare company and leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient’s treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk™.
Job Title: Regulatory Affairs Specialist
Department: Quality Assurance & Regulatory Affairs
Reports To: Sr. Director, Quality Assurance & Regulatory Affairs
Location: Laguna Hills, CA (onsite)
Hours: M-F 8am-5pm
JOB PURPOSE:
- Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast.
- Serve as regulatory lead for novel oncology diagnostic technologies integrating genomic and proteomic biomarkers.
- Ensure alignment with FDA expectations for Breakthrough Device Designation (BDD), SaMD, and clinical validation requirements.
- Collaborate cross-functionally to support development of clinically impactful breast cancer risk assessment tools.
ESSENTIAL RESPONSIBILITIES:
- Develop and execute regulatory strategies for De Novo and Breakthrough Device submissions.
- Author and compile high-quality FDA submissions including device description, intended use, software documentation, and clinical evidence.
- Lead FDA interactions including Q-Submissions, Pre-Subs, and deficiency responses.
- Translate complex AI/ML algorithms and biomarker data into clear regulatory documentation.
- Collaborate with Clinical, Biostatistics, Data Science, and Software teams on validation strategies.
- Ensure alignment with QMS and regulatory standards (IEC 62304, ISO 14971).
- Support regulatory positioning of prognostic and predictive oncology claims.
EXPERIENCE & QUALIFICATIONS:
- 6+ years regulatory experience in medical devices or digital health.
- Direct experience leading De Novo submissions (required).
- Experience with SaMD and AI/ML-based algorithms strongly preferred.
- Strong knowledge of FDA regulatory frameworks and guidance for SaMD.
- Experience with clinical validation of diagnostic or predictive models.
PREFERRED QUALIFICATIONS:
- Experience with oncology diagnostics or multi-omic assays.
- Familiarity with CLIA/CAP laboratory environments.
- Experience with Breakthrough Device Designation submissions.
- RAC certification preferred.
EDUCATION:
- Bachelor’s degree in science, engineering, or related field (advanced degree preferred).
ANNUAL COMPENSATION:
- $90,000-$140,000 DOE
The above list represents the general duties considered essential functions of the job and is not to be considered an exhaustive description of all the work requirements that may be inherent in the position.
ABOUT PRELUDEDX
PreludeDx is an Innovative Healthcare company and leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient’s treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk™.
Job Title: Laboratory Technician
Department: Anatomic Pathology
Reports To: Laboratory Manager
Location: Laguna Hills, CA
Hours: 1:00pm-9:30pm Tues-Sat.
Job Purpose
The Lab Tech is responsible for a multitude of pre-analytical and post-analytical support services in a high complexity testing CLIA certified laboratory.
Essential Responsibilities
- Prioritize and monitor cases throughout the day
- Routinely interface with Pathologists
- Troubleshoot missing or delayed cases
- Provide status updates of cases as required
- Ensure that all actions taken on behalf of a client or a patient are appropriately documented in the current information systems and are according to standard operating procedures’
- Support services for the laboratory, sales and clients
- Responsible for client services duties as assigned by the supervisor
- Label, scan slides and prepare slide boxes for shipment
- Maintain organized pathology reports
- Responsible for specimen accessioning and data entry in the LIS
- Responsible for logistics duties as assigned by the supervisor
- Use personal protective equipment appropriately and demonstrate safe work practices in accordance with laboratory and company policy. Maintain a clean and safe work environment
- Demonstrate excellent customer service skills
- Organize and file slides that have been stained and reviewed
- Extract and synthesize clinical data from pathology reports into format that can be used in a clinical database
- Performs other duties as assigned
The above list represents the general duties considered essential functions of the job and is not to be considered an exhaustive description of all the work requirements that may be inherent in the position.
Requirements
- Knowledge of Histotechnology and Immunohistochemistry in a clinical setting
- High School Diploma required
- Associate’s Degree or Bachelor’s Degree preferred
- Working knowledge of MS Office
- Ability to adapt to changing procedures, policies and work environment
- Good data entry skills
- Ability to communicate effectively and follow written and verbal instructions
- High level of accuracy and attention to detail
- Ability to work in a fast paced team environment
- Ability to multitask and prioritize with little supervision
ABOUT PRELUDEDX
PreludeDx is an Innovative Healthcare company and leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient’s treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk™.
Job Title: Customer Care Representative I
Department: Lab Operations
Reports To: Customer Care Manager
Location: Harrisburg, PA
Compensation: $18-20/hr
Hours: 11am -7:30pm M-F
DESCRIPTION
The primary objective of the Customer Care Representative I is to deliver exceptional customer service by efficiently addressing client inquiries and retrieving missing information. This role also involves accurately receiving, verifying, prioritizing, and facilitating the tracking of patient samples within the lab. Additionally, the representative ensures timely distribution of patient results and coordinates the return of samples to clients.
ESSENTIAL RESPONSIBILITIES
- Provide exemplary customer service.
- Receive packages.
- Utilize excellent verbal and written communication skills in order to coordinate with subjects, team members, other departments and outside institutions.
- Answer phones, route calls appropriately, greet visitors in a courteous manner.
- Assist sales team/clients with questions and obtaining patient results.
- Accessioning & data entry.
- Track internal and external samples.
- Organize and assist in the retrieval of missing patient information.
- Responsible for faxing and mailing patient reports in a timely manner.
- Filing as needed.
- Prepare detailed Excel reports.
- Maintain an organized work area.
The above list represents the general duties considered essential functions of the job and is not to be considered an exhaustive description of all the work requirements that may be inherent in the position.
REQUIREMENTS
- High School Diploma required.
- Bachelor’s in Biology, Biological Science, Chemistry preferred.
- Laboratory experience or strong interest preferred.
- Strong attention to detail, interpersonal skills.
- Ability to multi-task in a fast-paced environment while working independently with a diverse subject population.
- Requires strong computer and organizational skills and the ability to prioritize shifting work demands.
- Requires proficiency in Microsoft Office suite of programs including Word, Excel and PowerPoint.
- Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
- Knowledge of querying and solid analytical skills with ability to compile data from many sources and define designs to use data.
ABOUT PRELUDEDX
PreludeDx is an Innovative Healthcare company and leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient’s treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk™.
Job Title: Customer Care Representative I
Department: Lab Operations
Reports To: Customer Care Manager
Location: Laguna Hills, CA
Compensation: $20-25/hr
Hours: 9am-5:30pm M-F
DESCRIPTION
The primary objective of the Customer Care Representative I is to deliver exceptional customer service by efficiently addressing client inquiries and retrieving missing information. This role also involves accurately receiving, verifying, prioritizing, and facilitating the tracking of patient samples within the lab. Additionally, the representative ensures timely distribution of patient results and coordinates the return of samples to clients.
ESSENTIAL RESPONSIBILITIES
- Provide exemplary customer service.
- Receive packages.
- Utilize excellent verbal and written communication skills in order to coordinate with subjects, team members, other departments and outside institutions.
- Answer phones, route calls appropriately, greet visitors in a courteous manner.
- Assist sales team/clients with questions and obtaining patient results.
- Accessioning & data entry.
- Track internal and external samples.
- Organize and assist in the retrieval of missing patient information.
- Responsible for faxing and mailing patient reports in a timely manner.
- Filing as needed.
- Prepare detailed Excel reports.
- Maintain an organized work area.
The above list represents the general duties considered essential functions of the job and is not to be considered an exhaustive description of all the work requirements that may be inherent in the position.
REQUIREMENTS
- High School Diploma required.
- Bachelor’s in Biology, Biological Science, Chemistry preferred.
- Laboratory experience or strong interest preferred.
- Strong attention to detail, interpersonal skills.
- Ability to multi-task in a fast-paced environment while working independently with a diverse subject population.
- Requires strong computer and organizational skills and the ability to prioritize shifting work demands.
- Requires proficiency in Microsoft Office suite of programs including Word, Excel and PowerPoint.
- Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
- Knowledge of querying and solid analytical skills with ability to compile data from many sources and define designs to use data.
ABOUT PRELUDEDX
PreludeDx is an Innovative Healthcare company and leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient’s treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk™.
Job Title: Medical Biller/Collector
Department: Revenue Cycle
Reports To: Director, Revenue Cycle Management
Location: Laguna Hills, CA (onsite)
Compensation: $28-30/hr
Hours: 8am-5pm M-F
Description
This position will perform collections and medical billing for various regional and national payers, including Federal, State, Third Party (HMO, PPO, IPA, TPA Indemnity) and Patient Billing. Qualified candidates must be able to (1) Review accounts for billing accuracy in order to maximize reimbursement. (2) Persuasive and tenacious follow-up on claims status (3) Appeal, and re-bill or forward claims for recalculation and / or adjudication as necessary. Must possess detailed knowledge of all medical benefit levels and have a thorough understanding of Federal, State, PPO, HMO, and Indemnity Plans structure. Must meet or exceed the standard level of performance on assigned accounts.
ESSENTIAL RESPONSIBILITIES
- Data entry, correct insurance assignment to patient accounts, insurance eligibility verification. Review/update demographics and patient information for accuracy.
- Working knowledge of appropriate coding systems; CPT, ICD-9 and HCPCS, coverage; LCD/NCD and reimbursement associated with such codes.
- Processing, validation of payer requests and processed claims via correspondence, remittance advice and EOBs (i.e., identification of payment discrepancies, inappropriate requests)
- Investigate all denied services to determine the reason for the service denial, appeal, if appropriate. Identify, report root causes associated with denials
- Timely, effective processing of assigned appeals including development, submission, tracking, reporting and evaluation of appeal outcomes (i.e., next steps, improved outcomes)
- Maximize utilization of Billing system, tools, and resources to support cash collection activities.
- Review and work various reports including aging, adjustments and credit balances.
- Comply with Federal and State legislation pertaining to all billing related matters.
- Comply with all Safety, Emergency, Hazard, OSHA, HIPAA, Quality Assurance and Administrative Plans, Policies, Guidelines, Protocol, and Standards.
- Support and maintain department cash and DSO goals
- Other duties as assigned
The above list represents the general duties considered essential functions of the job and is not to be considered an exhaustive description of all the work requirements that may be inherent in the position.
Requirements
High School Diploma and a minimum of four years related experience or a Bachelor’s degree from a four-year college or university; or equivalent combination of education and experience
- Working knowledge and prior hands-on experience of medical billing and reimbursement. Proficient in Microsoft Outlook, Excel, Word, the Inter and Intranet and other programs/software as necessary.
- Problem solving skills, using good judgment, attention to detail and follow-through are a must.
- Excellent customer service skills; excellent verbal and written communication skills. Ability to prioritize work, multi-task and time management skills.
- Support cross-trained culture
- Excellent troubleshooting and time management skills, attention to detail, utilizes time in constructive manner
- Ability to easily adapt to increased business demands
- Ability to effectively work with and resolve complex accounts & billing issues
- Self-starter, ability to work independently
- Flexible and reliable
- Ability to effectively prioritize and multi-task
- Ability to work in fast paced environment, perform under pressure, meet tight timelines
- Establish and maintain cohesive and good working relationships.
- Excellent communication and customer service skills; cooperative, work collaboratively and treat others in respectful, professional and supportive manner.
ABOUT PRELUDEDX
PreludeDx is an Innovative Healthcare company and leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient’s treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk™.
JOB TITLE: Clinical Laboratory Scientist
DEPARTMENT: R&D
REPORTS TO: CLS Manager
LOCATION: Laguna Hills, CA
COMPENSATION: 45-50/hour
HOURS: 8am to 5pm
JOB PURPOSE:
We are seeking a highly motivated and skilled licensed CLS to join our team. The ideal candidate will have experience in running Next Generation Sequencing (NGS) and knowledge of molecular biology techniques.
ESSENTIAL RESPONSIBILITIES:
- Ensure that the equipment is calibrated, maintained, and operated according to the manufacturer’s guidelines and standard operating procedures.
- Adheres to the CAP, CLIA and NYS regulations.
- Run protocols for sample collection, processing, storage, and tracking in LIMs to ensure the integrity and traceability of the samples throughout the NGS workflow.
- Run clinical and R&D samples for NGS and molecular biology techniques, including microdissection, FFPE nucleic acid extraction, NGS library preparation, sequencing, data analysis, and quality control measures with appropriate NGS controls.
- Perform and train other CLS’s on established NGS and molecular biology procedures, including macrodissection, FFPE nucleic acid extraction, NGS library preparation, sequencing, and data analysis, including quality control measures.
- Perform validation testing to ensure with selected reagents and controls to ensure the assay meets the required performance specifications.
- Perform validation studies to assess the performance characteristics of the NGS assay, including sensitivity, specificity, accuracy, precision, and reproducibility.
- Analyze and interpret data using appropriate statistical methods and software, including sensitivity, specificity, accuracy, precision and reproducibility.
- Maintain accurate records and documentation of experiments and results.
The above list represents the general duties considered essential functions of the job and is not to be considered an exhaustive description of all the work requirements that may be inherent in the position
POSITION REQUIREMENTS:
- Minimum 4 years as a certified or licensed clinical laboratory scientist
- California Clinical Laboratory Scientist (Highly Preferred: California Clinical Genetic Molecular Biologist Scientist license – CGMBS.)
- Must be well-organized, open-minded, decisive, and flexible. They must be able to communicate well with others, and work as a team. Good writing skills and and extensive computer experience are necessary
- Experience with Macrodissection, RNA extraction and downstream analysis
- Strong experience in development of targeted library, conducting sequencing NGS library preparation, sequencing, and data analysis
- Experience in project management and organization
- Excellent record-keeping and documentation skills
- Strong communication skills and ability to work in a team-oriented environment
- Validation and SOP writing experience a plus
- Must have superior work ethic, high energy level and be results oriented
- Internally motivated and self-starter; ability to make an impact
- Comfortable in a fast-paced environment
- Excellent oral and written communication skills
- Candidate must be a fast learner, naturally oriented toward problem solving, have superior work ethic, high energy level and be ambitious; good organizational skills
- Preferred Bachelor’s or Master’s degree in Molecular Biology, Biochemistry, or related field
- CLS license 4+ years
- Highly Preferred: California Clinical Genetic Molecular Biologist Scientist license – CGMBS
- Anatomic or Clinical Pathology experience
- Prior experience with NextGen sequencing instruments.
- Minimum of 4 years of molecular and histology experience within an anatomic pathology laboratory or clinical laboratory.
ABOUT PRELUDEDX
PreludeDx is an Innovative Healthcare company and leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient’s treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk™.