Kura Oncology
biopharmaceutical
Manager,BiosampleOperations
“Manager, Biosample Operations at Kura Oncology. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, biosample operations, clinical trial management, GCP, ICH guidelines. plans, implements, manages and drives biological sample logistics within Kura Oncology Phase I-IV Clinical Trials. advises on and delivers the biosample strategy within clinical program(s) in accordance with the requirements of ”
What You'll Achieve.
maximizing biosample sample accrual and quality; Ensures project level consistency occurs for biosampling across studies; support team objectives and ensure alignment with broader program activities
Industry & Context.
Analytical thinker with problem-solving skills; ability to identify risks and issues, and propose appropriate measures as required
Flexibility to travel domestically and internationally as required (~10%)
What They're Looking For.
Must Have
demonstrated ability for excellence in drug discovery and development, values-driven work style where integrity and grit drive all behaviors, decisions, and actions, Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education, Must understand the drug development process in order to effectively manage internal and external cross-functional teams, Proven ability to build relationships with external partners, CROs, and biosample vendors, In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Knowledge of regulations and requirements for clinical trial authorization and tissue storage and transfer in major countries, Project management skills with ability to identify risks and issues, and propose appropriate measures as required, Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members, Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines, Excellent verbal and written communication skills, Planning, organization and time management skills including the ability to support and prioritize multiple projects, Accountable for executing decisions made within the function, Collaborates with cross-functional partners as needed to support team objectives and ensure alignment with broader program activities, Proficiency with Microsoft Office
Nice to Have
4-6 years of clinical trial management experience, 2+ years of hands-on experience in clinical biosample project management, Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions, EU and Asia filing experience a plus
What You'll Do.
manages and drives biological sample logistics within Kura Oncology Phase I-IV Clinical Trials
advises on and delivers the biosample strategy within clinical program(s) in accordance with the requirements of quality
and ethical and regulatory standards
including ICH/GCP/GLP
Ensures standardization and harmonization of biosample activities across clinical trials
oversight of sample collection
maximizing biosample sample accrual and quality
Review clinical study protocols
and service provider laboratory scope of work documents for sample handling details
Ensures ethical use of biosamples collected in Kura Oncology clinical trials
Accountable for planning
and overseeing all operational activities required to manage the lifecycle of patient samples (oversight of sample collection at site
shipment to vendor for testing/processing
analysis and final sample disposition)
Ensures project level consistency occurs for biosampling across studies
Track and report on biosample management status/progress
Complete other duties as assigned by the manager
How You'll Work.
Team & Collaboration
collaboration with Clinical Trial Leaders (CTLs) and cross-functional development team; collaboration with internal and external team members; build relationships with external partners, CROs, and biosample vendors; work collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members; Collaborates with cross-functional partners as needed to support team objectives and ensure alignment with broader program activities
Communication Scope
Excellent verbal and written communication skills
Process & Methodology
clinical trial management experience, clinical biosample project management, Project management skills with ability to identify risks and issues, and propose appropriate measures as required, Planning, organization and time management skills including the ability to support and prioritize multiple projects
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