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Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Lead, Clinical Bioinformatics Operations

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Lead, Clinical Bioinformatics Operations is a leadership position overseeing the analysis and delivery of Next Generation Sequencing (NGS) data to clinicians, pharmaceutical partners, and academic collaborators. This position is responsible for the direct oversight of analysts responsible for the detailed review of NGS data from clinical, biopharma, and research and development sources. This position also serves as technical support related to operational and quality aspects of the team. The Lead role contributes to key strategic and operational initiatives within the Laboratory Operations department.

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

• Operational Support:

  • Assume responsibility for developing annotated genomic profiles of somatic aberrations based on massively-parallel sequencing (NGS) data, in the context of studies of cancer-patient samples.
  • Review genomic variant calls using proprietary and publicly available tools (e.g. Integrative Genomics Viewer) in collaboration with the scientific team.
  • Provide test results according to standard operating procedures with the best possible quality within defined turn-around times.
  • Provide support for standard and advanced analysis data deliverables.
  • Participate in on-call rotation and ability to effectively articulate responses under strict time constraints, escalating and re-prioritizing tasks where necessary.
  • Oversee and support daily and weekly operational tasks of analysts.

• Management Support:

  • Provide consultation, technical support, and guidance to clinical analysts in collaboration with scientists and other Leads.
  • Support operational and development initiatives to develop and foster growth opportunities amongst direct reports.
  • Be responsible for the supervision and competency of team, including conducting 1:1 meetings, setting performance objectives, and semi-annual goal setting and reviews.
  • Lead the training of new analysts including presentation of training topics, scheduling of training activities, and the tracking of sign-off for training completion.
  • Perform routine auditing and competency assessments for testing personnel per Quality/Regulatory compliance.

• Cross-Functional and Team Support

  • Be involved at cross-functional team meetings, developing and executing on strategic initiatives in collaboration with members of Research & Development, Technology, Medical, Quality, Regulatory, and Operations teams.
  • Monitor team quality and compliance commitments in collaboration with Quality and Regulatory teams.
  • Identify quality issues and provide support to Clinical Bioinformatics Analysts on quality issues, including completion of non-conformances, planned deviations, incident reporting, and Standard Operating Procedure updates in CLIA/CAP/FDA settings, ensuring appropriate department approval and training of team members is completed in a timely manner.
  • Contribute to updates to Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure compliance with current workflows.
  • Prepare discussion topics and presentations for internal team meetings in collaboration with team leadership.
  • Complete periodic weekend or off-hours shifts.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree in a Bioinformatics, Biology, or a related scientific field

• 4+ years of experience working with bioinformatics tools and databases (including but not limited to: NCBI, UCSC Genome Browser, IGV)

• 3+ years of cancer genomics experience in an academic or pharmaceutical/biotech environment

Preferred Qualifications

• Master’s Degree in Bioinformatics, Biology, or a related scientific field

• 1+ year(s) of direct management experience

• Experience with Next-Generation Sequencing data

• Substantive genomics research experience in rigorous academic setting

• Experience working within a CLIA certified clinical diagnostics laboratory

• Strong knowledge of cancer genomics

• Programming ability in Python, SQL, or R.

• Familiarly with UNIX environment

• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues

• Excellent organizational skills and attention to detail

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, 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.

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Internal applicants, please use your FMI email address.

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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)

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