Position Purpose:
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 1 b-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: â
Provides biomarker operational expertise and guidance to one or more cross-functional 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
Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
Delivers the operational elements of the biomarker management plan
Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
Identifies areas of best practice and process improvements; may lead or be a representative on functional groups goals, initiatives and work-streams
Ensures study and biomarker operational adherence to ICH/GCP and SOPs
Qualifications:
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
Strong experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Skills & Knowledge:
Experience 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
Competencies
Strategic Agility
Inspiring and Influencing
Teamwork and Collaboration
Communication
Technical and Business Expertise
Achieving Results
Other:
Some travel may be required
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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.
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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 .
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