· Job facts
You will report to the HGR Officer and partner closely with the global biosample operations teams across the enterprise. You will be recognized as a leader and work autonomously in both local as well as global cross functional study teams.
As a Biosample Operations China Lead, you will provide biosample operational expertise to one or more cross-functional local or global study teams through all phases and stages in accordance with the appropriate quality standards and applicable local regulations.
WHAT YOU WILL DO
· PROVIDE BIOSAMPLE OPERATIONS GUIDANCE TO CLINICAL CHINA STUDY TEAMS AND GLOBAL STUDY TEAMS FOR CHINA RELATED ACTIVITIES by planning, coordinating, and overseeing all operational activities required to manage the lifecycle of study samples (collection, processing, analysis, data delivery and final disposition).
· LEAD THE DEVELOPMENT OF A CHINA SPECIFIC BIOMARKER MANAGEMENT PLANWITHIN CLINICAL STUDIESbased on input from scientific and operational stakeholders to execute biosample operational strategies in China
· PROVIDE INPUT TO HGRAC APPLICATION to support Country Study Managers - when applicable - and within Biosample Operations' remit.
· PARTNER CLOSELY WITH BIOMARKER SCIENTISTS AND BIOSAMPLE OPERATIONS PROGRAM LEADS LOCALLY AND GLOBALLY to align study specific activities with program sample collection strategies. Evaluate the operational feasibility of specific testing in China and provide input to global program teams.
· PROVIDE OPERATIONAL INPUT AND RECOMMENDATIONS INTO STUDY RELATED DOCUMENTATION AND PROCESSES (e.g. protocol, ICF, HGRAC applications)
· PRESENT CHINA STUDY SAMPLE COLLECTION STRATEGY AT OPERATIONS TEAM MEETINGS AND CHINA INVESTIGATOR MEETINGS
· CONTRIBUTE TO LOCAL LAB/ REGIONAL VENDOR SELECTION FOR SPECIFIC TESTING in collaboration with Biosample Ops Lead, biomarker scientist, Procurement and based on technology expertise, performance and compliance.
· ESTABLISH BIOSAMPLE ANALYSIS AND DATA DELIVERY MILESTONES AND ENSURE ACCURATE TRACKING AND REPORTING OF BIOSAMPLE METRICS (sample collection, assay status, analyses updates). Provide study level updates to the study and global biomarker teams. Support study teams in addressing local vendor/site sample queries. Actively partner with Data Management to oversee and coordinate data format, and delivery timelines.
· PROVIDE DAY TO DAY OPERATIONAL MANAGEMENT OF CHINA BIOSAMPLE VENDORS. Partner with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions. Review central lab documents to ensure alignment with protocol and HGRAC submissions. Perform ongoing biomarker vendor management including development and oversight of scope of work, budget and performance management. Interact with vendors to help evaluate data size for compliance, plan sample shipments, export, storage, define data retention, ensure samples are analysed and data are transferred.
· IDENTIFY AREAS OF BEST PRACTICE AND PROCESS IMPROVEMENTS. Contribute to the development of internal guidelines within Biosample Operations' remit, based on HGRAC process and local regulations as well as program needs. Partner with relevant stakeholders, both locally and globally, to optimize processes for sample management in China.
· DEMONSTRATE AGILITY AND ABILITY TO PERFORM IN A HIGHLY FAST-PACED, MATRIX ENVIRONMENT WHERE CROSS-TEAM COLLABORATION IS CRUCIAL. Leverage excellent verbal and written communication skills to motivate teams, negotiate with peers and partners and influence across stakeholders.
Who we are
WHO YOU ARE
You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, rigorous and entrepreneurial spirit.
· Have a growth mindset and are excited about learning through experience
· Feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environments
· Have a 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
· Hold a Life Sciences degree in Scientific, Medical or Healthcare subject area. Further qualification, e.g. PhD and/or project management certification is desirable
· Bring extensive clinical development experience with evidence of working in teams running clinical studies
· Have a clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
· Have proven leadership skills, ability to successfully achieve results within a global, multi-cultural and geographically diverse team
· Have (preferably) vendor management experience
· Want to make a difference and find excitement in innovating practices, products and simplifying processes
· Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines, HGRAC regulations
· Are fluent in English (written and spoken)
At Roche/Genentech, we believe our people are Key to our success in bringing novel medicines to patients and we are fully dedicated to being a great place to work and to provide the services, tools and the environment where everybody feels empowered, trusted and is enabled to uncover his/her true potential. Come join us and help build a diverse and inclusive organization where patient centricity and patient access is a priority.