Clinical Biomarker Lead
1 day ago
We are seeking a highly skilled Clinical Biomarker Lead to develop and drive biomarker plans across clinical stage Infectious Disease programs. This position reports to the Director of Infectious Disease, Clinical Biomarkers.
Key Responsibilities
Evaluate technologies to identify, define, and implement the biomarker strategy to support the clinical development of Moderna's vaccines.
Develop biomarker plans with input from the research and clinical leads.
Manage biomarker assay labs to complete appropriate development, qualification, or validation studies in order to execute the clinical biomarker plan on time and with good quality.
Ensure the timely and efficient delivery of all biomarker operational aspects across vaccine clinical trials: accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from planning, collection, analysis, data delivery, and final sample disposition with support from the Biosample Operations Manager.
Develop and provide operational input and recommendations into all study-related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, and ensure collection, delivery, and analysis of biosamples in compliance with these documents as well as GCP/ICH.
Serve as a single point of contact for biomarker operations across vaccine teams, and with collaborators, assay labs, and CROs.
Responsible for the identification and selection of biomarker vendors in collaboration with the Translational Science/Research leads.
Manage the development and oversight of the biomarker analysis timelines, budget, risk, and quality plans.
Attend operations team meetings and monitor training, CRO kick-off meetings, as applicable, to deliver trainings on biomarker activities.
Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collection.
Requirements
MS (with at least 8 years pharmaceutical/biotechnology experience) or PhD (with at least 2-4 years of pharmaceutical or biotechnology experience) in a related science focus (i.e., immunology, molecular biology, biotechnology).
Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure.
Experience in Infectious disease programs (Ex: Human respiratory viruses / Human herpes viruses / HIV / Human Flaviviruses / Bacterial diseases) is highly desirable.
Diagnostic assay development and testing experience is desirable.
Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research, validation, and implementation.
Experience in managing third-party assay laboratories, collaborations, and budget management.
Strong communication and project management skills.
What We Offer
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
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, the infrastructure 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 people are 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 /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. We are 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. (EEO/AAP Employer)
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