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Biomarker Clinical Operations Lead in PDG
vor 1 Woche
Biomarker Clinical Operations Lead in PDG (m/f/d) - clinical/diagnostic / pharmaceutical/biotechnology R&D / clinical development / project management / biomarker analysis / vendor Management /English
Project:
For our customer a big pharmaceutical company in Basel we are looking Biomarker Clinical Operations Lead in PDG (m/f/d).
Background:
At Roche/Genentech Pharma Product Development (PD) Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. PD's mission is to improve patients' lives around the world through unique medicines that have a meaningful impact. Cross functionally we conduct global clinical trials, analyze results, monitor safety, and work with regulatory authorities to provide truly differentiated medicines to patients. Our primary therapeutic focus areas are Oncology, Hematology, Neurology, Immunology, Ophthalmology, Cardiovascular, Renal, and Metabolism. We attract, develop, and retain the most talented people in the industry, and have Development centers in Basel, Switzerland; South San Francisco, California; Welwyn Garden City, England; Mississauga, Canada; and Shanghai, China, as well as operations in many other countries.
The Biomarker Clinical Operations Lead (Biomarker Operations Project Manager accountable) in PDG at Roche/Genentech is responsible and accountable to provide BIOMARKER OPERATIONAL EXPERTISE by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data, for PDG clinical studies.
The perfect candidate : The ideal candidate is someone with a scientific education, 3+ years of experience with a minimum of 1 year in clinical operations in pharma. We are looking for a strong candidate able to come in and quickly support. This person should have good experience with vendor and project management working in a global matrix environment and experience with biomarkers in a pharma and clinical setting
Tasks & Responsibilities:
• Provide biomarker/IVD operational expertise to clinical study teams to ensure operational feasibility and quality data delivery
• Be accountable for the development of the BIOMARKER MANAGEMENT PLAN and the execution of deliverables for assigned drug and device studies (e.g. IVD clinical performance studies) in partnership with the Clinical Study Lead or designee
• Manage all study level biomarker operations activities for both clinical (i.e. drug) and IVD studies (e.g. manage vendor/testing sites, ICF/protocol input, eTMF/RACT set-up, sample/data flow, data quality and transfer set-up)
• Partner with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, shipping conditions and logistics for biomarker samples
• Lead identification, selection and oversight of BIOMARKER VENDORS, including development and oversight of scope of work, budget, ensuring quality delivery and performance
• Actively partner with Data Management to oversee and coordinate biomarker data format and delivery timelines
• COLLABORATE AND PARTNER with cross functional stakeholders (e.g. study team members, biomarker science, CDx, procurement, testing site monitors, diagnostic partners, central lab) to execute biomarker/IVD operational strategies, serving as a single point of contact for biomarker/IVD operations on multiple study teams
• Provide technical knowledge of aspects related to biomarker analyses (e.g. sample collection and handling, assay, device and imaging technologies)
• Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITY, ensuring adherence to ICH/GCP, SOPs, ISO 20916 and regulatory requirements
• Attend operations team meetings and investigator/monitor meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection, handling and IVD procedures
• Provide responses to biomarker sample/IVD related questions or issues from Health Authorities
• IDENTIFY AREAS OF BEST PRACTICE and process improvements and contribute to/lead initiatives (if requested)
• You will work on business priorities as directed
• Expectation of ongoing and sustained onsite presence in compliance with local requirements
Must Haves:
• Minimum Bachelor/Master in Life Sciences (in Scientific, Medical or Healthcare subject area). Further qualification, e.g. PhD and/or project management certification is desirable.
• 3+ years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
• Extensive clinical development experienc
