- Develop biomarker plans with input from the research and clinical leads.
- Identify, evaluate and select immunology, virology and diagnostic assays, technologies and laboratory vendors, in collaboration with the Translational Science/Research leads.
- Manage the biomarker testing, budgets, timelines, risks and quality.
- Contribute to data interpretation and publications, including drafting and reviewing data analysis, Clinical Study Reports (CSRs), publications and presentations.
- With support from the Biosample Operations Manager, ensure the timely and efficient flow of biomarker samples from planning, collection, and analysis, to final sample disposition.
- 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 compliance with these documents as well as GCP/ICH.
- Serve as a single point of contact for all biomarker functions across vaccine teams, and with collaborators, assay labs and CROs.
- Manage biomarker assay labs to complete appropriate development, qualification or validation studies in order to execute the clinical biomarker plan on time and with robust quality.
- Attend operations team meetings and deliver trainings on biomarker activities, as needed.
- Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collection.
- PhD/MD (with at least 1 year of pharmaceutical, biotechnology or clinical assay experience) or MS (with at least 6 years pharmaceutical/biotechnology experience) in a related science focus (i.e. immunology, virology, molecular biology).
- Experience in EBV virology, immunology, vaccinology, or pathogenesis, i.e. infectious mononucleosis or multiple sclerosis (MS).
- Experience with other infectious diseases is highly desirable.
- Solid experience in clinical, translational or biomarker assays during early through late phase clinical development, including experience with assay validation and implementation.
- Diagnostic assay development and testing experience is desirable.
- Experience in managing third party assay laboratories, collaborations and budgets.
- Strong communication and project management skills, including use of collaborative editing tools (e.g. Office365).
- Comfortable working in a fast-paced cross-functional/matrixed team environment.
- 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
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Senior Manager, Clinical Biomarkers, Infectious Diseases - Cambridge, United States - BioSpace
Description
Job DetailsThe Role:
Moderna is seeking a Senior Manager, Clinical Biomarkers to develop and drive the biomarker strategy for two clinical stage Epstein Barr Virus (EBV) vaccine programs as well as other Infectious Disease programs, as needed. This position reports to Modernas Director, Latent Virus and Global Health Programs, Clinical Biomarkers. In collaboration with the program teams, the Sr. Manager will develop, implement and oversee the biomarker strategies to assess the immunologic, virologic. and diagnostic clinical trial endpoints in support of the clinical development of Modernas vaccines.
Heres What Youll Do:
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 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 . (EEO/AAP Employer)
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