Vice President, Companion Diagnostic Development Operations at Foundation Medicine in Cambridge, MA
About the Job The Vice President, Companion Diagnostic (CDx) Development Operations partners closely with the cross-functional product lifecycle teams and operations team and is a member of Foundation Medicine's leadership team. This role provides an opportunity to engage in a cross-functional partnership to enable best-in-class precision medicine assays and requires creative and strategic thinking. The VP, Companion Diagnostic Development Operations is accountable for collaborating with Assay Development to transfer new assays or assay design changes from development to validation and from validation to operations/production. Additionally, this position is responsible for collaborating with regulatory affairs, biostats and biopharma to scope and execute validation of new CDx biomarkers. This position is responsible for designing and developing verification and validation studies in collaboration with the biostatistics team to ensure that assay design is fit for purpose. The incumbent collaborates closely with development teams and directs program efforts from validation through design transfer, is deeply involved in companion diagnostic partnering with pharma, supports FDA interactions, and ensures robust performance of Foundation Medicine assays. Key Responsibilities o Oversee development and execution of verification and validation studies in close partnership with regulatory affairs and biostatistics to support numerous CDx filings, new products and design changes. o Collaborate with operations team to establish and validate production lines for new products or design changes o Transfer validated assays to operations. o Ensure that Design Control principles are followed per our quality system. o Collaborate cross-functionally with product life cycle team to ensure best-in-class product availability. o Develop and manage substantial department budget. o Other duties as assigned. Qualifications Basic Qualifications Bachelor's Degree 10
years of professional work experience in a molecular testing laboratory, diagnostic manufacturing organization and/or a diagnostics service organization 6
years of experience in assay development, including 2
years of experience specifically in development and validation of NGS assays Preferred Qualifications Ph.D. or other advanced degree in a life science, engineering, chemistry or other scientific field 15
years of experience in molecular assay development, including 5
years of experience specifically in development and validation of NGS assays Experience working on FDA-regulated products under design controls Extensive experience validating sequencing assays Proven record of taking products from feasibility through production launch Strong history of achievement demonstrated by leadership activities, publications, presentations or other activities Commitment to meeting timelines and demonstrated record of meeting challenging goals Outstanding communication skills Collaboration skills and the ability to effectively communicate (written and orally) with internal and external team members on project activities Understanding of HIPAA and importance of privacy of patient data Commitment to FMI's values:
innovation, patients, collaboration, and passion Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law. About Foundation Medicine 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. 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.
Salary Range:
$250K -- $500K+
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
years of professional work experience in a molecular testing laboratory, diagnostic manufacturing organization and/or a diagnostics service organization 6
years of experience in assay development, including 2
years of experience specifically in development and validation of NGS assays Preferred Qualifications Ph.D. or other advanced degree in a life science, engineering, chemistry or other scientific field 15
years of experience in molecular assay development, including 5
years of experience specifically in development and validation of NGS assays Experience working on FDA-regulated products under design controls Extensive experience validating sequencing assays Proven record of taking products from feasibility through production launch Strong history of achievement demonstrated by leadership activities, publications, presentations or other activities Commitment to meeting timelines and demonstrated record of meeting challenging goals Outstanding communication skills Collaboration skills and the ability to effectively communicate (written and orally) with internal and external team members on project activities Understanding of HIPAA and importance of privacy of patient data Commitment to FMI's values:
innovation, patients, collaboration, and passion Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law. About Foundation Medicine 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. 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.
Salary Range:
$250K -- $500K+
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
