Clinical Biomarker Director, Therapeutic Operations (Infectious Disease or Rare Disease)
Moderna is seeking a Clinical Biomarker Director to develop and drive biomarker strategy across clinical compounds 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 Therapeutic Operations. This position will work collaboratively across several disease teams and associated compounds to ensure planning, execution and data delivery of the biomarker strategy for clinical trials conducted by Moderna.
- Evaluate technologies to identify, define and implement the biomarker strategy to support the clinical development of Moderna's compounds
- Develop the biomarker strategy with input from the research and clinical leads for the study
- Drive the biomarker strategy to ensure assay labs complete appropriate qualification or validation work in order to execute on the clinical biomarker plan on time and with good quality
- Ensures the timely and efficient delivery of all biomarker operational aspects across therapeutic area 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 in support from the Biosample Operations Manager
- Responsible for collaborating closely with Translational Science/Research leads and biosample manager to execute biomarker operational strategies, serving as a single point of contact for biomarker operations across 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
- Ensure collection, delivery and analysis of biosamples according to the protocol and in compliance with protocol, informed consent, local regulations as well as GCP/ICH
- Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
- Leads the development and finalization of the Biomarker Plan based on input from scientific and operational team members to deliver on biomarker operational strategies
- Develops and provides operational input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes.
- Attends operations team meetings and monitor training, CRO kick-off meetings, as applicable, to deliver trainings on biomarker
- Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data reporting.
- MS (with at least 8 years pharmaceutical/biotechnology experience) or Ph.D. (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 global vaccine experience
- Rare disease should have global experience with biologic or gene therapy
- 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
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.