Manager, Biosample Operations
$150k - $178kKura Oncology, Inc.
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 part of something bigger, with a lasting impact you can be proud of. To succeed at Kura, you will need a demonstrated ability for excellence in drug discovery and development, a roll‑up‑your‑sleeves attitude, and 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. The role is part of the Clinical Operations function, reporting to the Head of Clinical Operations or designee, and collaborates with Clinical Trial Leaders (CTLs) and the cross‑functional development team. Advises on and delivers the biosample strategy within clinical programs in accordance with quality, ethical, and regulatory standards, including ICH/GCP/GLP. Ensures standardization and harmonization of biosample activities across clinical trials, overseeing sample collection, processing, storage, and reconciliation to maximize 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. Ensures ethical use of biosamples collected in Kura Oncology clinical trials. Plans, coordinates, and oversees all operational activities required to manage the lifecycle of patient samples, including site collection, shipment to vendors for testing/processing, analysis, and final disposition. Maintains project‑level consistency for biosampling across studies and acts as the primary point of contact for project, clinical, and study teams; contributes to innovation and improvement activities in collection, processing, and data delivery. Tracks and reports on biosample management status/progress, addressing issues and resolutions. Collaborates with internal and external team members. Completes other duties as assigned by the manager. Job Specifications Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education. Minimum of 4-6 years of clinical trial management experience (preferred). At least 2 years of strong hands‑on experience in clinical biosample project management. Understanding of the drug development process 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. 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 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 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 (IND) and New Drug Application (NDA) 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. Kura’s Values 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 and development opportunities. Competitive compensation package. Bonus. 401(k) with employer contributions. Generous stock options. Employee Stock Purchase Plan (ESPP). 20 days of paid time off to start. 18 holidays (including summer & winter break). Generous benefits package with a variety of plans and 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 coffee talks, and more. 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 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. #J-18808-Ljbffr Kura Oncology, Inc.
$150k - $178k
ESSENTIAL JOB FUNCTIONS Plan, implement, manage, and drive biological sample logistics... ...clinical trials, working within Clinical Operations and collaborating with clinical trial... ...development teams. Advise on and deliver the biosample strategy within clinical programs in...SuggestedCasual workSummer holidayWork at officeHome office- Kura Oncology, Inc. in Boston is seeking a Manager for Biosample Operations to oversee biological sample logistics in clinical trials. The role involves ensuring compliance with ethical and regulatory standards, while overseeing sample collection, processing, and storage...Suggested
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