Manager, Biosample Operations
About The Position
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.
Requirements
- 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, 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.
- 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.
Nice To Haves
- EU and Asia filing experience a plus.
Responsibilities
- 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.
- 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.
- Reviews 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.
- Tracks and reports on biosample management status/progress, addresses issues, and resolutions.
- Collaborates with internal and external team members.
- Completes other duties as assigned by the manager.
Benefits
- Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a variety of plans available with a substantial employer match
- Paid Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
