Bachelor's degree in science/healthcare or equivalent education
4-6 years of clinical trial management experience preferred
2+ years of hands-on experience in clinical biosample project management
Strong understanding of the drug development process
Proven relationship-building skills with external partners and vendors
In-depth knowledge of GCP and ICH guidelines
Project management skills with risk identification and resolution capabilities
Responsibilities
Plan and implement biosample logistics for clinical trials
Advise on biosample strategy in line with quality and regulatory standards
Ensure standardization of biosample activities across trials
Review clinical study protocols and related documents for sample handling
Oversee lifecycle management of patient samples from collection to disposition
Track and report on biosample management status and address issues
Collaborate with internal and external team members
Benefits
Career advancement and development opportunities
Competitive compensation package
401K with employer contributions
Generous stock options and ESPP plan
20 days of PTO plus 18 holidays
Comprehensive benefits package with substantial employer match
Paid parental leave
In-office catered lunches and home office setup
Lifestyle and commuter stipends
Regular employee social activities
Full Job Description
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!
About Kura Oncology, Inc.
Kura Oncology, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines for the treatment of cancer. The company's pipeline consists of small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's lead drug candidate, tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase, in clinical development for the treatment of patients with solid tumors harboring HRAS mutations.
