Clinical Biomarker Sr. Manager, Clinical Operations (Infectious Disease)

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
October 22 2019
Ref
R1857
Discipline
Life Sciences, Biology
Organization Type
Biotech
The Role:

Moderna is seeking a Clinical Biomarker Lead to develop and drive biomarker strategy across clinical stage vaccines working collaboratively with cross functional therapeutic team members. The role will liaise with external assay laboratories, collaboration partners and CROs. This position reports to Moderna's Director of Clinical Biomarkers. This position will work collaboratively across several clinical teams and associated vaccine targets to ensure planning, execution and data delivery of the biomarker strategy for clinical trials conducted by Moderna.

Here's What You'll Do:
  • Evaluate technologies to identify, define and implement the biomarker strategy to support the clinical development of Moderna's vaccines
  • Develop the biomarker strategy with input from the research and clinical leads for the study(ies)
  • Drive the biomarker strategy to ensure assay labs 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


Here's What You'll Bring to the Table:
  • MS (with at least 8 years pharmaceutical/biotechnology experience); or PhD (with at least 2 years of pharmaceutical or biotechnology experience) in a related science focus (i.e. immunology, molecular biology, biotechnology).
  • Infectious disease should have vaccine experience in both early and late phase and preferably in global programs
  • Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure
  • Companion diagnostic development 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


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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