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
Who You Are
Life Sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
6+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Skills & Knowledge:
Thorough understanding of all aspects of clinical drug development, proven experience in strategic planning, proven ability to understand and critically assess the global clinical development plans, protocol design, resources needs, global budgets and timelines for programs applicable to biomarker operations strategy
Clinical or biological laboratory experience with evidence of involvement in the processing and/ or analysis of biological samples
Strong leadership and motivational skills developed through leading successful multi-functional matrix teams.
Ability to maintain knowledge of novel scientific technologies & platforms that may impact planning or ongoing operational strategies
Strong analytical skills, ability to analyze complex activities and information to arrive at logical conclusions
Previous experience with budget forecasting and analyzing biomarker vendor service capabilities is a plus
Demonstrated leadership, influencing, communication and project management skills
Demonstrated ability to think strategically and develop and execute biomarker/analytical operations strategies in a global setting.
Ability to anticipate and solve problems.
Demonstrated excellent team and interpersonal skills, ability to communicate with energy and passion, to engage and inspire others
Effective communication skills; fluency in verbal and written English, any other language skills may be an asset
Ability to work independently with appropriate consultation as needed
Functional or Line management (coaching, mentoring and developing staff) experience a plus
Collaboration and Teamwork
Inspiring and Influencing
Mobile: Some travel may be required
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
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