Clinical Biomarker Senior Manager, Vaccines
Proclinical is currently recruiting for a Clinical Biomarker Senior Manager of Vaccines for a leading biotechnology company located in Cambridge, MA. Successful candidate will develop and drive biomarker strategy across clinical stage vaccines working collaboratively with cross functional therapeutic team members.
- Evaluate technologies to identify, define and implement the biomarker strategy to support the clinical development of the company'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.
Skills and Requirements:
- MS (with 8+ years' pharmaceutical/biotechnology experience) or PhD (with 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Max Robinson at (+1) 929-388-1651 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.