Manager, Biosample Operations

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

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.

• 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.

• Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
• A minimum of 4-6 years of clinical trial management experience preferred.
• 2+ years of strong hands-on experience in clinical biosample project management preferred.
• 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,…