Sr. Manager, Biomarker Operations
Moderna
Summary
Moderna is seeking a Biomarker Operations Sr. Manager to support the clinical teams and to work across its clinical trials as well as with external biorepositories, assay laboratories and CROs. This position will work collaboratively across all therapeutic area teams to ensure implementation, compliance and support of biosample plans and management for clinical trials conducted by Moderna.
Job description
The Role
Moderna is seeking a Biomarker Operations Sr. Manager to support the clinical teams and to work across its clinical trials as well as with external biorepositories, assay laboratories and CROs. This position will work collaboratively across all therapeutic area teams to ensure implementation, compliance and support of biosample plans and management for clinical trials conducted by Moderna.
Here's What You'll Do
- Independently support the clinical teams driving agreed upon biomarker sample management plans for the clinical trials
- Lead the review of biomarker sections of clinical protocols, clinical kit development, study/lab manuals and consent forms
- Promote process improvements for clinical sample lifecycle
- Lead the development of processes and procedures for standardized language, biomarker usage, and data reporting
- Support clinical teams to ensure biosamples are compliant with informed consent and GCP/ICH
- Oversee clinical assay vendor logistics (routine sample analysis meetings, address sample issues, sample shipments)
- Lead efforts to resolve sample issues at Central Labs and 3rd-party vendors
Here's What You'll Bring to the Table
- Bachelor's degree in a life science-based subject; advanced degree preferred
- Minimum of 5 years of clinical research experience which must include sponsor experience
- Direct experience with clinical sample management
- Prior process development experience is very helpful
- Familiarity with databases is helpful
- Solid understanding of GCP/ICH is required
- Strong communication skills and attention to detail
- Demonstrated ability to multitask
Requirements
- Bachelor's degree in a life science-based subject; advanced degree preferred
- Minimum of 5 years of clinical research experience which must include sponsor experience
- Direct experience with clinical sample management
- Prior process development experience is very helpful
- Familiarity with databases is helpful
- Solid understanding of GCP/ICH is required
- Strong communication skills and attention to detail
- Demonstrated ability to multitask
Benefits
- Competitive healthcare
- Voluntary benefit programs
- Fitness support
- Mindfulness support
- Mental health support
- Fertility support
- Adoption support
- Surrogacy support
- Generous paid time off
- Volunteer days
- Sabbatical
- Global recharge days
- Year-end shutdown
- Savings and investments
- Location-specific perks
Company overview
Moderna, Inc. is a pioneering American biotechnology and pharmaceutical company headquartered in Cambridge, Massachusetts, that has revolutionized the field of medicine through its groundbreaking messenger RNA (mRNA) technology. Founded in 2010, the company has established itself as a global leader in RNA therapeutics, primarily focusing on mRNA vaccines and treatments. Moderna's innovative platform uses mRNA to provide cellular instructions for producing proteins that trigger immune responses, creating a new category of medicines with significant potential to improve patient outcomes across various therapeutic areas. The company gained worldwide recognition during the COVID-19 pandemic for developing one of the earliest and most effective mRNA vaccines, which demonstrated the transformative potential of its technology platform. Beyond infectious diseases, Moderna is advancing a diverse pipeline of 44 treatment and vaccine candidates across infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune conditions. With approximately 5,800 employees and a strong commitment to scientific innovation, Moderna continues to expand its manufacturing capabilities and research initiatives to deliver the greatest possible impact through mRNA medicines.