Sr. Director, Medical Devices, Molecular Testing and Biomarkers Regulatory Affairs
4 weeks ago
The Role:
Provide worldwide regulatory strategy and oversight to ensure Moderna can describe, and support processes required for commercialization of INT products (i.e., neoantigen selection (next generation sequencing and bioinformatics) as well as related to front end specimen collection. Provide regulatory strategy and oversight for all Moderna Companion Diagnostics, SaMD, convenience kits (specimen collection kits) as well as Combination Products across the Moderna pipeline. Develop and lead a small team of device/biomarkers regulatory experts to support this work as the pipeline grows and includes additional personalized/targeted therapies.
Here's What Youll Do:
Develop regulatory strategy and contribute to discussions related to specimen collection, chain of Identity processes and systems for INT products including software such as Maestro.
Support front-end specimen collection convenience kits and associated labeling for INT.
Regulatory strategy for any doctor/patient portals that may be required for commercialization of INT.
Provide regulatory strategy and support for portions of INT or device drug labels that may include specimen collection, descriptions of sample testing (i.e., next generation sequencing), our BIX algorithm use of a Companion Diagnostic, SaMD and Combination Products.
Regulatory strategy development around INT neoantigen selection (NGS and BIX) as a manufacturing process.
Regulatory support required for partnering activities related to INT, companion diagnostics, SaMD, convenience kits or combination products including discussions with business partners and vendors.
Provide regulatory strategy and regulatory support to teams considering the incorporation of companion diagnostics or SaMD in therapeutic programs.
Work closely with Moderna QA to ensure INT processes as well as any companion diagnostics, digital systems, SaMD and combination products meet Moderna quality system requirements.
Regulatory policy development associated with neoantigen selection of INT, companion diagnostics and SaMD.
Support HA RTQs associated with INDs or BLAs related to all areas of responsibility.
Build and lead a small team of device/biomarker regulatory experts to support Modernas growing pipeline of individualized and targeted therapies.
Heres What Youll Bring to the Table:
Bachelors degree at a minimum
Highly experienced biomedical leader with a minimum of 10 years of relevant industry experience with expertise in individualized therapies, oncology biomarker and companion diagnostic development.
Experience with process and products that include software validation. Experience with molecular technologies including IHC, PCR, NGS and related reagents, instruments and software.
Experience with regulatory requirements for devices worldwide. Demonstrated excellence in development and implement overarching therapeutic area biomarker, individualized therapy and CoDx strategies. In depth experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and companion diagnostics.
Experience and dedication to building a small motivated team.
Excellent leadership skills including motivation and delegation.
Excellent verbal and written communication and presentation skills.
High level of initiative and ability to work independently.
High level of business awareness.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Cambridge, Massachusetts, United States Moderna Therapeutics Full timeAbout the RoleWe are seeking a highly experienced Regulatory Affairs Director to lead our medical devices, molecular testing, and biomarkers regulatory strategy and oversight. As a key member of our team, you will be responsible for ensuring that our products meet the highest regulatory standards and are compliant with global regulations.Key...
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Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Provide worldwide regulatory strategy and oversight to ensure Moderna can describe, and support processes required for commercialization of INT products (i.e., neoantigen selection (next generation sequencing and bioinformatics) as well as related to front end specimen collection. Provide regulatory strategy and oversight for all Moderna Companion...
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