Manager, Biosample Operations

Kura Oncology•Boston, MA

10d

About The Position

The Manager, Biosample Operations plans, implements, manages, and drives biological sample logistics for Kura Oncology Phase I–IV clinical trials within Clinical Operations. Working under the Head of Clinical Operations or designee and in collaboration with Clinical Trial Leaders and cross-functional development teams, this role advises on and delivers biosample strategy in accordance with quality, ethical, and regulatory standards, including ICH, GCP, and GLP. The role promotes consistent biosample practices across trials and oversees sample collection, processing, storage, reconciliation, accrual, and quality. The Manager reviews study protocols, informed consents, laboratory documents, case report forms, and service-provider laboratory scopes of work for sample-handling requirements. The role ensures ethical use of clinical-trial biosamples and oversees the complete patient-sample lifecycle, from collection at sites through shipment, testing or processing, analysis, and final disposition. As the primary biosample contact for project, clinical, and study teams, the Manager tracks and reports progress, resolves issues, supports improvements in collection, processing, and data delivery, and collaborates with internal and external partners. Other duties may be assigned by the manager.

Requirements

Bachelor’s degree in a science or healthcare field, a nursing degree, or equivalent combined education.
A minimum of 4–6 years of clinical trial management experience is preferred.
Two or more years of hands-on clinical biosample project management experience is preferred.
Understanding of the drug development process to manage internal and external cross-functional teams effectively.
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, including identifying risks and issues and proposing appropriate measures.
Ability to work independently and collaboratively in a fast-paced, matrixed environment with internal and external team members.
Analytical thinking, problem-solving skills, and adaptability 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.
Accountability for executing decisions made within the function.
Ability to collaborate with cross-functional partners to support team objectives and align with broader program activities.
Flexibility to travel domestically and internationally as required, approximately 10%.
Proficiency with Microsoft Office.

Nice To Haves

Experience with Investigational New Drug (IND) and New Drug Application (NDA) submissions.
EU and Asia filing experience.

Responsibilities

Plan, implement, manage, and drive biological sample logistics for Phase I–IV clinical trials.
Advise on and deliver biosample strategy in line with quality, ethical, and regulatory standards, including ICH/GCP/GLP.
Standardize and harmonize biosample activities across clinical trials and oversee sample collection, processing, storage, and reconciliation.
Review protocols, informed consents, laboratory documents, case report forms, and laboratory service-provider scopes of work for sample-handling details.
Ensure the ethical use of biosamples collected in Kura Oncology clinical trials.
Plan, coordinate, and oversee the patient-sample lifecycle, including site collection, shipment, vendor testing or processing, analysis, and final disposition.
Ensure consistency of biosampling across studies and serve as the primary point of contact for project, clinical, and study teams.
Contribute to innovation and process improvements in sample collection, processing, and data delivery.
Track and report biosample management status and progress, and address issues and resolutions.
Collaborate with internal and external team members.
Perform other duties as assigned by the manager.

Benefits

Competitive compensation package
Annual target bonus
401(k) with employer contributions
Stock options
Employee Stock Purchase Plan (ESPP)
20 days of PTO to start
18 holidays, including summer and winter breaks
Generous benefits package with a variety of plans and a substantial employer match
Paid paternity and maternity leave
In-office catered lunches
Home office setup
Lifestyle spending stipend
Commuter stipend for the Boston office
Employee social activities, including happy hours, monthly birthday celebrations, and Kura Koffee Talks
Career advancement and development opportunities