Sr. Pathologist & Associate Medical Director
Company: Disability Solutions
Location: Morrisville
Posted on: April 18, 2024
Job Description:
About the Job
The Sr Pathologist and Associate Medical Director is involved in
all aspects of delivering FMI's clinical laboratory testing
services and serves as an internal subject matter expert, applying
medical knowledge to advise decision makers in support of FMI's
mission to transform cancer care. The Sr Pathologist is responsible
for review of patient samples, review of results generated from
genomic profiling and other methodologies, and approval of reports.
As an Associate Medical Director, the Sr Pathologist develops,
reviews, and approves policies and procedures to ensure consistent,
timely, and accurate clinical testing strategies; and participates
in instrument, IT and test methodology selection, qualification and
documentation; as well as new assay development, validation, and
operationalization. The incumbent also serves as an ambassador for
comprehensive genomic profiling through education and research
efforts within and external to FMI.
This is a regulated position and additional information may be
available from QA on the qualifications for this role pertaining to
regulatory guidelines.
Regular onsite work at the RTP location is an essential function of
this role.
Key Responsibilities
- For clinical and biopharma testing performed at FMI:
- Review patient specimens and accompanying documentation prior
to testing in collaboration with other applicable
stakeholders.
- Review test results and approve reports.
- As appropriate for the role, testing may include FoundationOne
CDx, FoundationOne Heme, FoundationOne RNA, FoundationOne
LiquidCDx, FoundationOne Tracker, and/or PD-L1 IHC assays, among
others.
- Function as an Associate Medical Director for the laboratory
operations to ensure compliance with regulatory guidelines and
promote audit readiness.
- Independently manage direct reports by providing mentorship,
direction, and performance feedback.
- Interface directly with clients to support patient
care.
- Support FMI Commercial Team initiatives and programs through
traveling to and administering programs at hospitals, cancer
centers, and academic medical centers.
- Participate in new assay development and validation, and
optimization of existing assays.
- Provide clinical expertise for strategic research initiatives
to expand new testing capabilities.
- Support Quality Assurance, Compliance, and Regulatory
activities.
- Perform research studies leading to abstracts, peer-reviewed
publications, and presentations at medical/scientific meetings that
highlight FMI assays and data.
- Provide subject matter expertise on established specialty
areas.
- Other duties as assigned.
Qualifications
Basic Qualifications
- Doctor of Medicine Degree
- Medical Licensure in the state of primary clinical laboratory
affiliation
- Formal pathology training
- American Board of Pathology - Anatomic Pathology
Certification
- 3+ years of experience in diagnostic pathology, biomedical
research, or biotechnology after completion of clinical
training
Preferred Qualifications
- American Board of Pathology - Clinical Pathology
Certification
- American Board of Pathology - Molecular Genetic Pathology
Certification
- Subspecialty training and/or expertise in cancer biology,
genomics or clinical trials
- Strong history of achievement demonstrated by leadership
activities, publications, presentations or other
activities
- Collaboration skills and the ability to effectively communicate
(written and oral) with internal and external team members on
project activities
- Process-oriented, flexible mindset and approach to creative
problem solving
- Demonstrated history of cross-functional leadership and/or
participation in cross-functional teams
- Demonstrated ability to:
- Meet deadlines
- Work well under pressure while maintaining a professional
demeanor
- Self-organize and operate effectively without day-to-day
oversight, while staying tightly connected to key leaders and teams
across the collaborations
- Work in a laboratory environment in the presence of chemicals
and reagents
- Understanding of the Health Insurance Portability and
Accountability Act (HIPAA) and the importance of patient data
privacy
- Commitment to reflect FMI's values: innovation, patients,
collaboration, and passion
#Onsite --
Essential
Keywords: Disability Solutions, Cary , Sr. Pathologist & Associate Medical Director, Executive , Morrisville, North Carolina
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