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Manager, Franchise Development

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.

Key Responsibilities

• 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.

Qualifications

Basic Qualifications

• 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;

Preferred Qualifications

• 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

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Internal applicants, please use your FMI email address.

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