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Kura Oncology Verified

Manager, Biosample Operations

BostonHybridFull TimeManager / Head$150,000–$178,000 /yrPosted 25 days ago

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Required skills

  • Biosample Operations
  • Clinical Trials
  • Clinical Operations
  • Clinical Trial Leaders
  • biosample strategy
  • quality
  • ethical and regulatory standards
  • ICH/GCP/GLP
  • sample collection
  • processing

Nice to have

  • Phase I-IV Clinical Trials
  • clinical biosample project management

Role summary

Kura Oncology is seeking a Manager, Biosample Operations to manage biological sample logistics for Phase I-IV clinical trials. This role involves developing and executing biosample strategies, ensuring compliance with quality and regulatory standards (ICH/GCP/GLP), and overseeing sample collection, processing, storage, and disposition. The Manager will collaborate with internal and external teams, manage vendors, and track project status. A Bachelor's degree in a science/healthcare field and 4-6 years of clinical trial management experience are preferred, with 2+ years in biosample project management. Strong knowledge of drug development, GCP/ICH guidelines, and project management skills are essential. The position is based in Boston and offers a hybrid work model.

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.

ESSENTIAL JOB FUNCTIONS:

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.

    • JOB SPECIFICATIONS:

  • 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

    • The base range for this role at the Manager level is $150,000 - $178,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

    #LI-RM1

    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 commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.

    Through our deep understanding of cancer biology and decades of experience in precision oncology, we are studying the underlying causes of treatment resistance. This enables us to design smart combination regimens with other cancer therapies to target tumors from multiple directions, with the goal of improving long-term clinical benefit.

    Kura developed and is commercializing KOMZIFTI® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.

    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.

    If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

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