Clinical Biomarker Director, Therapeutic Operations (Infectious Disease)
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 the Moderna's Head of Clinical Operations. 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 5 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
- 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
- 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.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale, and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.