Foundation Medicine, Inc.
Sr Pathologist and Associate Medical Director
Foundation Medicine, Inc., Boston, Massachusetts, us, 02298
Foundation Medicine, Inc.
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.
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.
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.
May independently manage direct reports, including Senior Pathologists, Pathologists, and Clinical Staff Pathologists in the execution of the pathology clinical services, and support their career development and growth.
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 ability to effectively communicate with internal and external team members
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.
Essential
LI-Onsite
About Foundation Medicine Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there’s no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.
Equal employment opportunity, including veterans and individuals with disabilities.
PI277949651
#J-18808-Ljbffr
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.
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.
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.
May independently manage direct reports, including Senior Pathologists, Pathologists, and Clinical Staff Pathologists in the execution of the pathology clinical services, and support their career development and growth.
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 ability to effectively communicate with internal and external team members
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.
Essential
LI-Onsite
About Foundation Medicine Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there’s no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.
Equal employment opportunity, including veterans and individuals with disabilities.
PI277949651
#J-18808-Ljbffr