Clinical Biomarker Operations Leader

United States, California, South San Francisco

Considering local candidates only. 

Position Purpose:
  • As a core member of the Biomarker Subteam (BMST) and the Companion Diagnostics Project Team (JPT), within Development Sciences, the Clinical Biomarker Operations Leader contributes at a broad and strategic level by developing, implementing and overseeing the Biomarker and Companion Diagnostics Operations strategy for gRED programs. 
  • The CBOL is accountable for the efficient delivery of biomarker operations across program(s) in accordance with time, cost and quality commitments including ICH/GCP and applicable regulations.
  • Provides program and indication- specific biomarker operational expertise, innovative and flexible operational solutions and options for the molecule’s Biomarker and CDx plan within the BMST and/ or JPT
  • Manage a team of 3-5 direct reports
Main Responsibilities and Accountabilities:
  • Provides biomarker operational direction and leadership for one or more clinical programs to ensure the delivery of biomarker operational activities in line with the biomarker strategy
    • Responsible for the leadership and alignment of the biomarker and companion diagnostics operational strategy for one or more complex programs
    • Provides strategic context and delivers the molecule’s biomarker operations and companion diagnostics plan using therapeutic area and indication expertise
    • Responsible for developing and executing the biomarker operations and companion diagnostics plan for a program including scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of budget and resources (in collaboration with gRED Biomarker Operations group leader), and development of high level operational strategies
    • Ensure timely execution of patient selection/stratification for clinical trials by working with internal stakeholders (including global line functions) and external partners (clinical research organizations and academic labs) for assigned program(s)
    • Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at a program level. 
    • Chairs Biomarker Working Group meetings, if applicable, and other meetings involving internal or external stakeholders (Biomarker Scientists, Operational Functions, Data Management, Research Pathology and Vendors as appropriate).
    • Optimize and drive specimen collection through presentations at Investigator Meetings and authoring study-related documents eg Pathology manuals
    • Has broad understanding of the science and technology of projects and displays technical skills and knowledge required. Actively educates other team members through knowledge sharing. 
  • Creates and manages biomarker operations program timelines, resources, budget, analyze risk and quality 
    • Drives setting of biomarker operational program goals and milestones and monitors progress 
    • Reviews the biomarker operational plan with the biomarker scientist for alignment within the TA, indication or molecule. 
    • Responsible to communicate and to follow up on any relevant changes to the biomarker operations plan which require implementation across the program.
    • Communicates initial budget, timelines and changes to stakeholders as appropriate.
    • Oversees the operational implementation of the program biomarker strategies.
    • Accountable for biomarker analysis budget forecasts, with appropriate input from vendors and biomarker scientists to ensure efficient expenditure and minimal variance between actual and planned spend. 
    • Ensures biomarker analysis data is available in accordance with the biomarker program plan, as applicable
    • Ensures escalation of issues and risks that significantly affect biomarker program timelines, budget or quality to the Biomarker Scientist, Clinical Operations, Clinical Science and Global Procurement (GPPS).
    • Responsible for biomarker operations program-level decision making, risk identification and mitigation planning, ensuring escalation and resolution as appropriate.
  • Provides direction and oversight of biomarker outsourced activities on a program level 
    • Responsible for leading the aligned identification and selection of biomarker vendors in collaboration with the biomarker scientist and GPPS across a program 
    • Contributes to contract and budget negotiations led by Business Manager.
    • Maintains an overview of status and issues, and proactively communicate progress, challenges or changes that may impact timelines to relevant stakeholders, including Biomarker Scientists and Clinical Program Leaders.
  • Manage and provide leadership, strategic direction for new staff
    • May recruit and hire new staff, onboard/train new staff to comply with company and regulatory standards as applicable. Trains staff to a level of increased independence
    • Mentors and coaches gRED Biomarker Operations staff and provides feedback to group leader, as appropriate, on individual’s performance
  • Identifies and contributes to areas of best practice and process improvements
    • Provides program leadership to matrix teams within gRED Biomarker Operations by providing program specific guidance, clinical biomarker operations expertise, strategies, best practices, lessons learned and direction to achieve results
    • Ensures successful handover to PD Biomarker Operations when program has moved to late stage. Continue to provide Biomarker Operations expertise and operational strategy even after program LIP, in cases where PD BMO resource is not yet identified/onboarded.
    • Onboard/train Biomarker Operations for PD and US Medical Affairs 
    • Works with scientific stakeholders to identify novel and innovative biosample collection and processing techniques and ensures logistical feasibility across a program
    • Represents Biomarker Operations or takes a leadership role in non-molecular projects (NMPs) and actively contributes to the optimization of existing as well as the development of new processes within and across Therapeutic Areas (TAs) and across the broader GNE/Roche organization e.g. Global Human Specimen Management Policy, Pharma Respository Governance Committee, Global Protocol and ICF template development, etc. 
    • Leads by example and creates a positive work environment by encouraging mutual respect, innovation and accountability at all levels
  • Ensures biomarker operational program adherence to ICH/GCP and SOPs