Full Time | Cambridge | Massachusetts | United States
About the Job
The Manager, Franchise Development provides technical oversight of companion diagnostic (CDx) development projects in collaboration with an external biopharma partner. The position works cross-functionally to ensure FMI meets the requirements for successfully launching a CDx on FMI's FDA-approved comprehensive genomic profiling platform.
• Serve as the franchise development representative for companion diagnostic projects and collaborate with biopharma partners and the internal team, leveraging academic and industry knowledge to influence cross-functional initiatives spanning Development, Regulatory Affairs, Quality Assurance, Clinical Operations, Biomarkers and Biometrics, and Program and Project Management.
• Provide technical oversight to assigned cross-functional, multi-disciplinary project(s) in order to meet the requirements for successfully launching and maintaining CDx claims on the F1CDx and/or F1LCDx platform.
• Partner with the Franchise Development Leader, Project Manager, Alliance Manager, and other team members to develop detailed requirements and a granular work plan for projects.
• Participate in development and completion of all components of assigned CDx projects, including but not limited to:
· Product development, if required (e.g., new biomarker development or redevelopment);
· Technical capabilities;
· Analytical validation plans and reports;
· Regulatory approach and requirements; and,
· Product launches.
• Support internal team meetings to coordinate activities required to deliver on the work plan.
• Serve as the primary counterpart to the biopharma development co-lead during regular Joint Project Team (JPT) meetings.
• Provide status updates and escalate issues to the Franchise Development Lead as necessary.
• Speak to technical issues or requirements at regulatory meetings with health authorities, including FDA.
• Travel to attend annual conferences, partner facing meetings and FDA meetings as needed.
• Occasional other duties pertinent to research and development, as assigned.
• Degree in Molecular Biology, Cell Biology, Biochemistry or another life science field
• At least one of the three following education and experience combinations:
· (a) Bachelor’s Degree and 6+ years of experience in product development or a related industry; or
· (b) Master’s Degree and 4+ years of experience in product development or a related industry;
• Prior professional experience:
· with Next Generation Sequencing/NGS technology, design control, and medical device regulatory filings
· working on Joint Project Teams in either a leadership or team member capacity
· participating on, making impactful contributions to, and influencing a multi-disciplinary team
· working on cancer genomics or within the cancer genomics industry
• History of balancing and achieving success on multiple concurrent product development initiatives
• Applied knowledge of product development processes with familiarity in the design control process
• Excellent organization and attention to detail
• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
• Demonstrated ability to perform successfully under pressure while maintaining a professional demeanor
• Ability to travel up to 25%
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI's values: passion, patients, innovation, and collaboration
Internal applicants, please use your FMI email address.
The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.
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