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Clinical Biomarker Sr. Mgr/Associate Director, Clinical Operations - Zika

Cambridge, MA

Posted: 08/19/2020 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2620

Job Description


Our client is seeking a Clinical Biomarker Lead to develop and drive biomarker strategy across clinical stage vaccines working collaboratively with cross-functional therapeutic team members. This position reports to the Director of Clinical Biomarkers, and the role will liaise with external assay laboratories, collaboration partners and CROs. 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 our client’ s clinical trials.

Responsibilities:
  • Evaluate technologies to identify, define and implement the biomarker strategy to support the clinical development of client' 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.

Requirements:
  • PhD with at least 6 years of pharmaceutical/biotechnology experience in a related science focus (i.e. immunology, molecular biology, biotechnology)
  • 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

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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