Irvine, California, United States · Hybrid
$283k–$320k/yr
Description AIM OF THE POSITION The incumbent, with expertise in Oncology and/or Molecular Pathology, will analyze and understand the laboratory and clinical aspect of high complexity tests, as offered by Agendia, Inc., …
Skills: Oncology, Molecular Pathology, Histopathologic Examination, Immunohistochemical Stains, Genomic Assays
Jacksonville, Florida, United States · Remote OK
$130k–$165k/yr
Description ** Starting at $250k inclusive of Base Salary + Comm AIM OF THE POSITION The Molecular Oncology Specialist’s (MOS) primary responsibilities are to develop and successfully execute sales strategies to ensure a…
Skills: Strategic Selling, Account Management, Sales Forecasting, KOL Relationship Management, Medical Presentation
Chicago, Illinois, United States · On-site
$130k–$165k/yr
Description **Starting at $250k inclusive of Base Salary + Comm AIM OF THE POSITION The Molecular Oncology Specialist’s (MOS) primary responsibilities are to develop and successfully execute sales strategies to ensure ac…
Skills: Strategic Selling, Account Management, KOL Relationship Management, Oncology Sales, Sales Forecasting
Irvine, California, United States · On-site
$48/hr–$53/hr
Description **Shift will be Wednesday - Sunday 6:00am - 2:30pm Job Summary: The CLS works under minimal supervision, and is responsible for complex molecular diagnostic testing laboratory procedures using all types of qu…
Skills: DNA/RNA Extraction, PCR, RT-PCR, DNA Sequencing, Microarray Technology
Irvine, California, United States · On-site
$25/hr–$30/hr
Description **Shift will be Monday - Friday 10:00am-3:30pm AIM OF THE POSITION The Laboratory Support Associate will ensure proper handling of all specimens received and prepare specimens for laboratory testing. This pos…
Skills: Specimen Handling, Data Entry, LIS, Quality Assurance, Inventory Management
Irvine, California, United States · On-site
$30/hr–$33/hr
Description **Shift will be Monday - Friday 10:00am-4:00pm Job Summary: Performs all aspects of a Histotechnician, including cutting, staining and imaging sections. Essential Duties and Responsibilities: Performs histolo…
Skills: Microtomy, Tissue Embedding, H&E Staining, Imaging, Laboratory Automation
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The Associate Medical Director analyzes high-complexity tests in oncology and molecular pathology to interpret immunohistochemical tests and genomic assays. They provide clinical expertise to resolve case issues and collaborate with laboratory operations to ensure high quality and turnaround times.
Candidates must be an M.D. or D.O. with certification in Anatomic Pathology and an active California medical license. A minimum of 5 years of experience in Anatomical Pathology is required, with molecular diagnostics experience highly preferred.
Description
The incumbent, with expertise in Oncology and/or Molecular Pathology, will analyze and understand the laboratory and clinical aspect of high complexity tests, as offered by Agendia, Inc., in order to select areas of tumor for molecular analyses, interpret immunohistochemical tests, and explain the clinical and pathological significance of his/her interpretations. This i a hybrid position.
1. Reports to Senior Medical Director, Laboratory Services
2. Cooperates with relevant departments (such as Laboratory Operations, QA, and commercial teams) within Agendia
3. Participates in:
Requirements
o Conduct histopathologic examination of submitted specimens to assess their adequacy for testing and make recommendations when limited specimen is available.
o Provide interpretation of immunohistochemical (IHC) stains as needed.
o Review batch and instrument quality control IHC stains as needed.
o Participate in day-to-day operations, including sign-out of Agendia’s genomic assays with full-time availability to interact with clients for pre-analytical, analytical, and post-analytical questions.
o Provide expertise and assistance to technologists and technicians to resolve case issues.
o Serve as delegated Clinical Consultant when assigned by Senior Medical Director.
o Works closely with clinical and administrative staff to ensure the highest standards of turnaround time, quality, and customer service are maintained.
o Assist with management of the Pathology Report Data Entry process.
o Follow established policies, procedures, continuous quality improvement objectives, safety, environmental, and/or control standards.
o Assist with clinical studies sponsored by Agendia.
o Assist as needed to perform other related duties and special projects as required.
The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.
o Works closely with Laboratory Operations, Customer Service, Product Support, Marketing, and all possible interfacing groups or teams
o Works with external customers (such as ordering physicians and pathology institutions) and regulatory agencies
o Must be a M.D. or D.O. with certification in Anatomic Pathology (AP) or Anatomic/Clinical Pathology (AP/CP)
o Active unrestricted Medical License to practice in the state of California is required.
o Additional subspecialty education in Surgical Pathology or fellowship training (with Board eligibility or certification) in Molecular Genetic Pathology is preferred but not required.
o Trained in pathology residency programs in US (fellowship preferred), with at least 1 year of experience in clinical practice or industry
- 5+ years clinical and laboratory experience
- Must have 5+ years of Anatomical Pathology Experience
- Experience with Molecular Diagnostics highly preferred
o Certificate of Qualification in Histopathology and/or Molecular and Cellular Tumor Markers from New York State Department of Health is preferred but not required
o Knowledge and experience using diagnostic equipment, such as conventional or digital microscope
o High degree of care and attention with strict adherence to defined clinical testing protocols
o Demonstrated skills and high level of attention to detail in technical data interpretation and ability to troubleshoot
o Skill and ability to provide genomic testing support for cancer patients
o Skill in utilizing customary computer programs (such as word processing, spreadsheet, etc.) and ability to learn internal software programs for diagnostic purposes
o Skill and ability to communicate verbally and in writing with all levels of staff
o Skill and ability to learn and collaborate with others in a complex, multi-functional environment
o Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area.
o Skill and ability to evaluate, interpret and present highly complex data for a series of studies (prospective and retrospective)
o Strong communication & presentation skills
- Ability to summarize and communicate the key points for others to effectively and expeditiously make important business decisions
o Must have demonstrated organizational skills to manage multiple projects simultaneously.
o Ability to work independently
o Working knowledge of FDA regulations and the clinical laboratory regulatory environment are a plus.
o Must be able to work a hybrid schedule
· PRIVACY NOTICE: To review the California privacy notice, click here: https://agendia.com/privacy-policy/
· Employees must not be classified as an excluded individual who is prohibited from participation in any Federal health care program.
o Exhibits professional maturity, confidence, and competence
o Sound and accurate judgment
o Sets and achieves challenging goals
o Demonstrates persistence to overcome obstacles.
o Applies creative, out-of-the box thinking to overcoming obstacles and taking advantage of opportunities in the marketplace.
o Works well in a fast-paced environment filled with many priorities and time
Established ADA (Americans with Disabilities Act) requirements
Working conditions (inside or outside the office).
o Ability to travel domestically, up to 10%
Other duties as required (this is the last responsibility for every job description).
MammaPrint® + BluePrint® provides you with actionable insights throughout your patient’s breast cancer journey.
Agendia, a precision oncology company, helps physicians and patients make personalized treatment decisions in early-stage breast cancer. MammaPrint® (MP), 70-gene breast cancer recurrence assay, is the only FDA-cleared (microarray) risk of recurrence test and is CE marked (IVDR-certified). BluePrint®(BP), 80-gene molecular subtyping assay, evaluates the underlying biology of a tumor to determine growth drivers. MP+BP are commercially available genomic tests, supported by clinical, guideline, peer-reviewed, and real-world evidence. They can be ordered on core biopsies or surgical specimens.* *FDA Intended Use: the test is performed for breast cancer patients with Stage I or Stage II disease with tumor size ≤5.0cm and lymph node negative. The MP FFPE result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors. Coverage criteria for majority of US health plans include early-stage breast cancer, tumor size less than or equal to 5.0cm (≤5.0cm), up to 3 positive lymph nodes, independent of receptor status, as validated in the 6,693 patient MINDACT trial. IVDR-CE mark Intended Use: you are a female breast cancer patient with Stage I or Stage II disease who is lymph node negative or lymph node positive with up to 3 positive nodes and for patients with stage III disease. The MP FFPE result is indicated for use by physicians and should be interpreted with other clinico-pathological factors. BP was developed and its performance characteristics determined by Agendia. It has not been cleared or approved by the US FDA, which determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This test was performed at Agendia, Inc (05D1089250), which is certified under CLIA as qualified to perform high-complexity clinical laboratory testing. It is CE-marked for use in Europe. Social media policy: agendia.com/legal-compliance
Offices: 22 Morgan, Irvine, CA 92618, US
MammaPrint® + BluePrint® provides you with actionable insights throughout your patient’s breast cancer journey.
Agendia, a precision oncology company, helps physicians and patients make personalized treatment decisions in early-stage breast cancer. MammaPrint® (MP), 70-gene breast cancer recurrence assay, is the only FDA-cleared (microarray) risk of recurrence test and is CE marked (IVDR-certified). BluePrint®(BP), 80-gene molecular subtyping assay, evaluates the underlying biology of a tumor to determine growth drivers. MP+BP are commercially available genomic tests, supported by clinical, guideline, peer-reviewed, and real-world evidence. They can be ordered on core biopsies or surgical specimens.* *FDA Intended Use: the test is performed for breast cancer patients with Stage I or Stage II disease with tumor size ≤5.0cm and lymph node negative. The MP FFPE result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors. Coverage criteria for majority of US health plans include early-stage breast cancer, tumor size less than or equal to 5.0cm (≤5.0cm), up to 3 positive lymph nodes, independent of receptor status, as validated in the 6,693 patient MINDACT trial. IVDR-CE mark Intended Use: you are a female breast cancer patient with Stage I or Stage II disease who is lymph node negative or lymph node positive with up to 3 positive nodes and for patients with stage III disease. The MP FFPE result is indicated for use by physicians and should be interpreted with other clinico-pathological factors. BP was developed and its performance characteristics determined by Agendia. It has not been cleared or approved by the US FDA, which determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This test was performed at Agendia, Inc (05D1089250), which is certified under CLIA as qualified to perform high-complexity clinical laboratory testing. It is CE-marked for use in Europe. Social media policy: agendia.com/legal-compliance
Offices: 22 Morgan, Irvine, CA 92618, US
