Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies through all phases (phase 1b-IV) supported by PD and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
Main Responsibilities and Accountabilities:
Provides biomarker operational expertise and guidance to global Study Management Teams (SMTs)
Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) * (collection, processing, analysis, data delivery process and final sample disposition) .
Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
Develops and maintains effective working relationships with SMT members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors, where applicable
Builds and maintains effective and efficient high performing biomarker sample* analysis & data delivery . Supports relevant stakeholders in their accountabilities, responsibilities and deliverables to drive decisions on timelines
Responsible for the identification and selection of biomarker vendors in collaboration with the BOPL, biomarker scientist, GPPS and diagnostics/CDx managers; ensuring appropriate cross-functional input is incorporated into the scope of work
Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at study level
Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans,
Ensures biomarker operational tracking and project management tools are utilized to meet the needs of the operations team and ensures reporting to the Biomarker Operations Program Leader (BOPL).
Supports the development of the biomarker analysis budget and manages it on a study level. Communicates variances in the budget to the BOPL or GSM as appropriate.
Establishes biomarker sample analysis and data delivery milestones and ensures accurate tracking and reporting of Biomarker sample* metrics.
Provides study level updates to stakeholders (BTALs & BOPLs), clinical study teams and biomarker teams including sample collection, assay status and analysis updates
Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
Responsible for assessing feasibility for biomarker operations plans on clinical studies across related functions
Leads the development and finalization of the Biomarker Management Plan (BMP) based on input from scientific and operational stakeholders to execute biomarker operational strategies
Provides operational input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes.
Attends operations team meetings and investigator meetings, monitor training, CRO kick-off meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection and handling procedures
Provides responses to biomarker sample* related questions or issues from Health Authorities.
Provides biomarker* operational input into the development of protocol feasibility questionnaires to ensure sites can meet sample handling needs for the study
Provides input into the development of SMT goals.
Delivers the operational elements of the biomarker management plan
Proactively manages biomarker sample analysis and data delivery timelines and communicates any variances to the SMT, BOPL and biomarker scientists and implements contingencies in consultation with key stakeholders.
Primary contact for internal and external stakeholders to maintain oversight of biomarker vendor performance, issues, their resolution and coordinates any corrective action in collaboration with GPPS.
Actively partners with Data Acquisition Specialists and Data Management to oversee and coordinate biomarker data format and delivery timelines
Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
Partners with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, kit contents, shipping conditions and logistics for biomarker samples
Performs ongoing biomarker vendor management including development and oversight of scope of work, budgets (invoice review & reconciliation) and performance management
Serves as primary point of contact for laboratories performing biomarker analysis and hence supports the biomarker outsourcing process through effective vendor management
Identifies areas of best practice and process improvements
Participates in Product Development Global Operations initiatives and programs as assigned
May lead or be a representative on functional groups goals, initiatives and work-streams
Ensures study adherence to ICH/GCP and SOPs
*in some cases may also be applicable to bioanalytical samples in partnership with the bioanalytical managers
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.
3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Skills & Knowledge:
Extensive clinical development experience with evidence of working in teams running clinical studies
Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus
Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
Project management 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
Planning, organizational and time management skills
Highly flexible in a fast pace global matrix environment
Professional interpersonal skills, excellent oral/written communication and influencing skills
Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team
Creates team culture and promotes team spirit.
Global Vendor Management experience preferred
Good knowledge of ICH GCP
Inspiring and Influencing
Teamwork and Collaboration
Technical and Business Expertise
Other: • 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.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.