Full Time | Cambridge | Massachusetts | United States
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.
About the Job
The Associate Director, Data Management oversees data management for FMI's BioPharma and Academic research collaborations, in addition to FMI sponsored research. This position supervises the data management team, provides training and mentorship to team members, and manages the day-to-day projects and resources within the team. This role contributes to the development and implementation of the Data Management strategy and ensures consistent implementation and evolution of processes and procedures in support of Clinical Trials. The Associate Director is the primary liaison between Data Management and FMI's Information Technology teams. The incumbent also supports relationships with FMI’s Laboratory, Biopharma and Academic Clinical Operations and Computational Biology teams, as well as external partners’ project teams.
This position requires the ability to travel nationally and internationally (up to 10%).
• Lead a team of data management personnel, mentoring, and supporting their ongoing professional development and growth.
• Manage, review, and approve new Data Management work for our Biopharma and Academic partnerships.
• Oversee daily deliverables for our research collaborations.
• Facilitate team meetings by creating agendas, identifying priorities/working groups, and distributing communications/minutes
• Act as the key point of contact for FMI's Information Technology teams to propose, prioritize, test, and implement improvements to FMI’s data reporting applications.
• Support external messaging with respect to FMI technology updates.
• Develop scalable solutions to enhance technical support for data management processes.
• Strategically represent Data Management on cross-FMI initiatives and governance committees (LCT).
• Support development and maintenance of Clinical Trial Data Operations Standard Operating Procedures (SOPs) and WIs.
• Assist with prioritization of Data Operations deliverables and technology requests.
• Provide point of escalation support to team.
• Act as Data Management's subject matter expert during audits from partners and regulatory agencies.
• Maintain occasional availability to work outside of regularly scheduled shift.
• Other duties as assigned.
• Bachelor’s degree or equivalent in scientific field or equivalent combination of education, training and experience
• 8+ years of data management experience in a biotech, pharmaceutical, or Clinical Research Organization (CRO) environment handling complex clinical data sets including genomic data and experience in clinical oncology trials
• 5+ years of experience with direct people management or leading a team
• Master’s Degree
• Experience working within Good Clinical Practices, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Clinical Data Interchange Standards Consortium (CDISC) and other necessary guidelines
• Experience in a CRO or clinical research vendor environment
• Experience in scientific data management in all phases of project design and analysis
• Experience with cross-functional collaboration and facilitating strategic and tactical planning for excellent interaction with outside collaborators and clients
• Familiarity with Study Data Tabulation Model/STDM
• Ability to help scale functional areas to include additional data responsibilities and team members
• Demonstrated ability to effectively communicate, influence, and lead both with and without authority
• Demonstrated ability to perform both at a strategic leadership level as well as in a hands-on capacity
• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow in a fast-paced, dynamic environment
• Demonstrated ability to learn new software and technology quickly
• Demonstrated ability to work under pressure while maintaining a professional demeanor
• Proven demonstration of leadership, strategic, and system thinking
• History of applying proactive, forward thinking to problems
• Genomic data background and experience
• Technical proficiency in using relational databases
• Excellent communication skills, including ability to diffuse difficult conversations
• Understanding of HIPAA and the importance of maintaining patient document privacy
• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration
Equal Opportunity and Affirmative Action Plan Employer
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)
Internal applicants, please use your FMI email address.