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Sr. Manager, Clinical Biomarkers - Autoimmune

Cambridge, MA 02139

Posted: 10/18/2023 Employment Type: Contract Job Category: Operations and Development Job Number: 3688

Job Description

Our client is seeking a Clinical Biomarker Scientist to develop and drive biomarker plans across clinical-stage autoimmune programs. This position reports to the Director of Clinical Biomarkers for Therapeutics. The Sr. Manager / Manager will work collaboratively across multiple clinical teams (internal or external CROs) to ensure planning, execution, and data delivery of biomarker lab data for clinical trials. 

Responsibilities:
  • Work in collaboration with the research team and clinical lead to support clinical biomarker development plan of early-phase autoimmune programs
  • Evaluate and identify the right technologies and suitable assays to implement the biomarker plan
  • Ensure assay labs complete appropriate development, qualification or validation studies in order to execute the clinical biomarker plan on time and with good quality
  • Provide scientific inputs on PK & biomarker sample collection, shipment, and disposition with support from the Biosample Operations Manager to ensure the timely and efficient delivery of all biomarker operational aspects
  • Manage and oversee the development plan of the bioassay timelines, budget, risks, and quality
  • Serve as a primary point of contact for biomarker operations across autoimmune teams, and with collaborators, assay labs, and CROs
  • Develop and provide operational inputs and recommendations into all study-related documentation (including study protocol, lab manual, informed consent form, investigator brochure, clinical study report, and IND/BLA documents) and processes, and ensure collection, delivery, and analysis of biosamples in compliance with these documents as well as GCP/ICH
  • Lead clinical biomarker subteam meetings and participate in clinical team meetings
Requirements / Qualifications:
  • MS (with at least 6 years of pharmaceutical/ biotechnology experience) or Ph.D. (with at least 2-3 years of pharmaceutical or biotechnology experience) in a related science focus on immunology.
  • Broad knowledge of standard and emerging biomarker assay technologies, such as ligand binding assays, LC-MS, IHC, flow cytometry, and omics approaches, and experience in the application of these to address current and future needs within the autoimmune portfolio
  • Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure
  • Solid experience in the application of clinical biomarkers during the development of assets is preferred, including experience with clinical translational research, assay development validation, troubleshooting, and implementation
  • Experience in CRO management, biomarker assay qualification/validation, familiarity with assay development under regulated environment (CLIA, GCP/GCLP or equivalent) is preferred.
  • Ability to quickly absorb new information and development an understanding of the target biology, diseases indications, and technology platform
  • Strong communication, project management, and organizational skills
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