Biomarker Operations Project Manager

In the Pharma Product Development (PD) Global Clinical Operations (PDG) department, 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. PDs 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.

TASKS AND RESPONSIBILITIES
The Biomarker Clinical Operations Lead (Biomarker Operations Project Manager accountable) in PDG 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. As Biomarker Clinical Operations Lead, your responsibilities will include as directed:

• 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

Who you are:

• 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 experience with evidence of working in teams running clinical studies
• Strong experience with vendor and project management
• Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelines
• Have a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
• Experience working in a global and matrix environment
• Excellent collaboration, communication, influencing and presentation skills
• Critical reasoning skills including the identification and resolution of complex problems
• Detail oriented with the ability to work independently and manage multiple competing priorities
• Fluency in English with additional language skills as an asset

Pay Rate Range: $100-155/hr depending on experience