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.
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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!
