About the Job
The Medical Director works to expand and strengthen the FMI Germany team in Penzberg. FMI's mission is the preparation, sequencing, and analysis of tissue and blood samples from cancer patients to produce a report that supports the personalized treatment of the patient. The start-up mentality and strong team spirit distinguishes FMI from other companies in the field, which is reflected in fast decision making, mutual support, and a high degree of trust. The Medical Director strives to increase our international footprint and drive strategic development of Foundation Medicine in Europe and beyond.
• Provide overall medical oncology leadership for Foundation Medicine, in addition to helping shape and implement the vision and strategy for the international markets
• Function as EU Medical Director with duties including review and approval of standard operating procedures, non-conformances, planned deviations, installation/operational qualifications, and other technical documentation as well as audits.
• Provide input into design of the company’s comprehensive tumor genome analysis tests, including but not limited to test contents and performance specifications.
• Design and implement clinical strategies to establish the analytical and clinical validity of the company’s comprehensive tumor genome analysis tests.
• Manage external medical collaborations to execute upon the vision and strategy.
• Interface for reporting molecular information to physicians in the context of relevant scientific and medical knowledge and evaluate medical significance of non-conforming examinations.
• Report to VP, Global Medical Affairs and partner closely with the Foundation Medicine Medical Team on the responsibilities described above. Ability to travel internationally up to 25% of the time.
• Other duties as assigned.
• 10+ years of pathology experience
• 2+ years of experience in supervising high-complexity testing
• Board Certification as Pathologist licensed to practice in the jurisdiction where laboratory is located
• Comprehensive knowledge of ISO15189 and CAP/CLIA requirements
• Fluent German Speaker
• Experience in a fast growth commercial organization with product launch experience
• Demonstrated extensive ambassador experience
• Understanding of diagnostic and oncology trends with an ability to integrate knowledge or research from multiple data sources to develop and support assumptions
• Well-versed in molecular diagnostic practices and processes – both at the laboratory level, as well as in the commercialization of diagnostic products (e.g. local medical practice, reimbursement activities, regulatory compliance requirements)
• Scientific understanding of cancer molecular pathways and mechanisms of disease, treatment response, and resistance
• Demonstrated understanding of clinical evidence base and active research behind the use of molecular markers in treatment selection
• Ability to interpret genomic, clinical, and efficacy data, including the strengths and weaknesses of study design and the applications of results to standard of care and clinical practice
• Strong communicator and collaborator who can effectively influence and drive change within the organization
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion
Internal applicants, please use your FMI email address.
Foundation Medicines European subsidiary is located within the Roche Campus in Penzberg, Germany, just a couple of miles south of Munich. Roche Penzberg is one of Europe’s largest biotechnology centers, employing around 6,200 people from over 50 nations.
In addition to laboratory operations, the site functions as hub for internal collaborations and partnerships. The central location in Europe and within the Penzberg campus allow for a strong synergy between Foundation Medicine, various national and international partners and Roche.
The Foundation Medicine team in Penzberg consists of several groups, such as Laboratory Operations, Client Services & Accessioning, Computational Biology, Quality Assurance, Automation Engineering, Project management, Finance and IT. Many of the Roche amenities on campus can also be used by Foundation Medicine employees, such as the gym, canteen, and bus services.
Learn more about our German location from our Project Manager, Barbara.