At GSL, our mission is to revolutionise biomarker discovery and development by harnessing the power of machine learning (ML). We are dedicated to improving diagnostics and advancing treatment options in rare, cardiac, and neurodegenerative disease. Through cutting-edge ML algorithms, we develop panels of biomarkers that can be used to diagnose, stratify and monitor patients across the entire clinical development pathway.
GSL CoreLabs specialises in delivering high-complexity multiomic testing to pharma, biotech, and healthcare partners. The Head of Regulated CoreLabs will be responsible for building and leading a high-performing, compliant laboratory team - establishing the people, processes, and culture required to deliver complex clinical-grade testing at scale. This role is central to growing GSL’s international credibility as a leading provider of multiomic solutions for clinical development programs.
Responsibilities
* Lead on GSL’s Regulated Core Lab Services Programme
* Validate mass spectrometry assays to relevant clinical standard (ISO15189, CLIA, GCLP)
* Assess and validate additional assay platforms (i.e NuLISA)
* Independently applies scientific principles to achieve project objectives, including the design and execution of complex experiments, and analysis and interpretation of data under limited supervision
* Assessing viability and feasibility of new assays
* Execute project deliverables for biomarker studies in clinical trials by project scope of work and within sponsor-specific timelines.
* Manage day-to-day operational aspects of clinical biomarker projects.
* Assist in preparation and adherence to trial documents i.e., Project Protocols, Data Transmittal Forms etc.
* Ensure project documentation are complete and stored appropriately.
* Manage key documents/processes i.e., Project Management Plan, Communication Plan, Escalation Plan, Risk Management Plan, and appropriate Clinical Trial Management Systems (CTMS).
* Identification of scope out quests – working with appropriate team(s) to revise work orders to meet changing needs and requirements.
* Prepare metrics reporting for client and senior management.
* Manage Core Lab Resources and ensure timely delivery of analysis.
* Support of pre-sales process – methodologies, procedures & pipelines.
* Creating and Contributing to Standard Operating Procedures of the overall service, and individual projects.
* Liaise with external study teams to ensure smooth delivery of project metrics – this may include attendance at progress meetings as required.
* Some domestic and international travel will be required.
* Contribute to laboratory duties to maintain smooth laboratory operation
* Troubleshoot equipment issues
* Adhere to laboratory safety protocols and human tissue sample handling procedures
* Carry out any other duties as are within the scope, spirit and purpose of the job as requested by the Line Manager.
* Training and supervision of junior staff
Qualifications
* Degree in biochemistry/related subject essential
* 5+ years’ experience in mass spectrometry operation and method development
* Experience in delivery of mass spectrometry biomarker projects desirable
* Quality Assurance/Compliance in clinical trials settings; Experience in Clinical trials/mass spectrometry in a clinical environment desirable
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