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EU Medical Director (m/f/d)

  • Penzberg, Bavaria DE, Germany, 82377
  • Full Time

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.

 

Key Responsibilities

• 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.

 

Qualifications

Basic Qualifications

• 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

 

Preferred Qualifications

• 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

 

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)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.

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The past twelve months have been beyond exceptional and nobody can deny the impacts the global corona pandemic had on our daily lives. However, there were many positives. Our working environment had to quickly adapt to the new situation and employers and employees just the same had to accommodate to the new circumstances. Continued or exclusive work from remote has become “the new normal” – and to everyone’s surprise, it is working just as well. 

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