- 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.
- 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
- 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
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Sr. Pathologist - Morrisville, United States - Foundation Medicine
Description
Job DescriptionAbout 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
Basic Qualifications
Essential
About Us
Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
