Manager, Biosample Operations at Kura Oncology, Inc. Full Time

The Manager, Biosample Operations plans, implements, manages and drives biological sample logistics within Kura Oncology Phase I-IV Clinical Trials, working within our Clinical Operations function, under the leadership of the Head of Clinical Operations (or designee) and in collaboration with Clinical Trial Leaders (CTLs) and cross-functional development team.

Position Accountabilities:

• The Manager, Biosample Operations 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 and oversight of sample collection, processing, storage, and reconciliation, maximizing biosample sample accrual and quality.
• Review clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details.
• Responsible for ensuring ethical use of biosamples collected in Kura Oncology clinical trials.
• Accountable for planning, coordinating, 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 and is the primary point of contact for project, clinical, and study teams; contributing to innovation and improvement activities in collection, processing and data delivery.
• Track and report on biosample management status/progress, address issues, and resolutions.
• Collaborate with internal and external team members
• Complete other duties as assigned by the manager.

Job Requirements

• Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
• 5+ years of clinical trial management experience preferred.
• 2+ years of strong hands-on experience in clinical biosample project management preferred.
• Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions, EU and Asia filing experience a plus.
• Must understand the drug development process in order to effectively manage internal and external cross-functional teams.
• Proven ability to build strong 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.
• Flexibility to travel domestically and internationally as required (~10%).
• Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions, EU and Asia filing experience a plus.
• Proficiency with Microsoft Office