Clinical Biomarker Lead
4 days ago
The Role:
Moderna is seeking a Clinical Biomarker Lead to develop and drive biomarker plans across clinical stage Infectious Disease programs. This position reports to Moderna's Director of Infectious Disease, Clinical Biomarkers. The Associate Director will work collaboratively across several clinical teams (internal, external CROs) to ensure planning, execution, and data delivery of biomarker lab data for clinical trials conducted by Moderna.
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 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.
- 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.
- This role is based in our new LEED-certified HQ in Cambridge, MA, and is expected to be in office 70% of the time with flexibility to work from home up to 30%.
Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop and deliver innovative medicines. We are committed to advancing the field of mRNA technology and to making a meaningful impact on human health. Our team is passionate about developing and delivering innovative medicines that improve the lives of patients and their families. We are proud to be an equal opportunity employer and are committed to creating a diverse and inclusive work environment. If you are passionate about advancing the field of mRNA technology and making a meaningful impact on human health, we encourage you to apply for this exciting opportunity.
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