Associate Director, Clinical Biomarkers Therapeutics

The Role:

Moderna is seeking a Clinical Biomarker Lead to develop and drive biomarker plans across clinical-stage rare disease programs. This position reports to Modernas Director of Clinical Biomarkers for Therapeutics. The Associate Director will work collaboratively across multiple clinical teams (internal or external CROs) to ensure planning, execution, and data delivery of biomarker lab data for clinical trials conducted by Moderna.

Heres What Youll Do:

• Work in collaboration with the research team and clinical development team to support clinical biomarker development plan of Modernas early-phase rare disease programs

• Evaluate and identify the right technologies and suitable assays to implement the biomarker plan

• Ensure assay labs complete appropriate development, qualification or validation studies to execute the clinical biomarker plan on time and with good quality

• Serve as SME to lead the clinical biomarker-related efforts, including the implementation of clinical biomarker plans, vendor selection, assay development and data delivery

• Provide scientific inputs on biomarker sample collection, shipment, and disposition with support from the Biosample Operations Manager to ensure the timely and efficient delivery of all clinical biomarker operational aspects

• Manage and oversee the development plan of the bioassay timelines, budget, risks, and quality

• Serve as a primary point of contact for biomarker operations across therapeutic research and development teams, and with collaborators, assay labs, and CROs

• Develop and provide operational inputs and recommendations into all study-related documentation (including study protocol, lab manual, informed consent form, investigator brochure, clinical study report, and IND/BLA documents) and processes, and ensure collection, delivery, and analysis of biosamples in compliance with these documents as well as GCP/ICH

• Lead clinical biomarker subteam meetings and participate in clinical team meetings

Heres What Youll Bring to the Table:

• MS (with at least 8 years of pharmaceutical/biotechnology experience) or Ph.D. (with at least 3 years of pharmaceutical or biotechnology experience) in related research focusing on rare, autoimmune, or metabolic diseases.

• Broad knowledge of standard and emerging biomarker assay technologies, such as ligand binding assays, LC-MS/MS, genetic sequencing, IHC, flow cytometry, and omics approaches, and experience in the application of these to address current and future needs within the rare disease portfolio

• Experience in clinical translational or biomarker work and its role across drug development from the early phase through licensure

• Solid experience in the application of clinical biomarkers during the development of assets is preferred, including experience with clinical translational research, assay development validation, troubleshooting, and implementation

• Experience in CRO management, biomarker assay qualification/validation, familiarity with assay development under regulated environment (CAP/CLIA, GCP/GCLP, IVDR or equivalent) is preferred.

• Ability to quickly absorb new information and development an understanding of the target biology, diseases indications, and technology platform

• Strong communication, project management, and organizational skills

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 options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous 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 thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-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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