Manager, Biosample Operations
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Job Description
Biosample Operations Manager overseeing patient-sample logistics across Kura Oncology’s precision-medicine clinical trials. Coordinating vendors, compliance, collection, processing, storage, and disposition.
Responsibilities:
- Plan, implement, manage, and drive biological sample logistics within Kura Oncology Phase I–IV clinical trials
- Advise on and deliver biosample strategy in accordance with quality, ethical, and regulatory standards, including ICH, GCP, and GLP
- Standardize and harmonize biosample activities across clinical trials
- Oversee sample collection, processing, storage, and reconciliation to maximize sample accrual and quality
- Review clinical study protocols, informed consents, laboratory documents, case report forms, and laboratory scope-of-work documents
- Ensure ethical use of biosamples collected in clinical trials
- Plan, coordinate, and oversee the lifecycle of patient samples from site collection through vendor shipment, testing/processing, analysis, and final disposition
- Serve as the primary point of contact for project, clinical, and study teams on biosampling
- Track and report biosample management status and progress; address issues and resolutions
- Collaborate with internal and external team members
- Complete other duties as assigned
Requirements:
- Bachelor’s degree in science/healthcare, a nursing degree, or equivalent combined education
- Minimum of 4–6 years of clinical trial management experience preferred
- 2+ years of hands-on clinical biosample project management experience preferred
- Understanding of the drug development process
- Ability to build relationships with external partners, CROs, and biosample vendors
- 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, including identifying risks and issues and proposing appropriate measures
- Ability to work independently and collaboratively in a fast-paced, matrixed team environment
- Analytical and problem-solving skills; ability to adapt to changing priorities and deadlines
- Excellent verbal and written communication skills
- Planning, organization, and time management skills; ability to prioritize multiple projects
- Ability to execute decisions made within the function
- Ability to collaborate with cross-functional partners and support team objectives
- Willingness to travel domestically and internationally as required, approximately 10%
- Experience with IND and NDA submissions; EU and Asia filing experience is a plus
- Proficiency with Microsoft Office
Benefits:
- Competitive compensation package
- Annual target bonus
- Career advancement/development opportunities
- 401(k) with employer contributions
- Generous stock options
- ESPP plan
- 20 days of PTO to start
- 18 holidays, including summer and winter break
- 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 for the Boston office
- Regular employee social activities, including happy hours, monthly birthday celebrations, and Kura Koffee Talks
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