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.
Watch the video to see how each member has the chance to make a real impact.