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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.
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
Kura's Values that are used for candidate selection and performance assessments:
- We work as one for patients
- We are goal-focused and deliver with excellence
- We are science-driven courageous innovators
- We strive to bring out the best in each other and ourselves
The Kura Package
- 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!
Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.
Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura's website at www.kuraoncology.com.
Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.