Director/Sr. Director, Biosample Operations

ESSENTIAL JOB FUNCTIONS:

The Director/Sr. Director, Biosample Operations plays a crucial role in overseeing biosample operations activities critical to the success of Kura Oncology clinical trials.  This role requires a seasoned professional with extensive experience with implementing biosample operations strategy as well as strong leadership skills to guide a team responsible for maintaining biosample integrity and accessibility.  This position will work within our Clinical Operations function, under the leadership of the Vice President, Clinical Trial Management and in collaboration with Clinical Trial Leaders (CTLs), Clinical Development, Clinical Biomarkers and Companion Diagnostics, Clinical Pharmacology and cross-functional development team.

Position Accountabilities:

• The Director/Sr. Director, Biosample Operations leads the biosample management team and is accountable for planning and managing all project management and operational activities required to operationalize biosample strategies based on trial designs and program objectives.   
• Partner with cross-functional team to establish biosample management operational strategy in alignment with program clinical development plans.  
• Lead Biosample Operations team to develop/enhance processes and deploy best practices to drive efficiency and deliver consistent results.  Stay current with industry trends/emerging technologies and apply innovation to enhance biosample management practices. 
• Lead/Co-Lead Governance with key laboratory vendors
• Implement KPIs to measure performance with a focus on time, cost, and quality. 
• Foster collaborative relationships with internal team members and external vendors to establish clear expectations for input/outputs to/from the Biosample Management team. 
• 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.
• Lead biosample risk management strategy. 
• Responsible for ensuring ethical use of biosamples collected in Kura Oncology clinical trials.
• Lead the internal team to manage the biosample lifecycle.  Biosample lifecycle management includes planning, coordinating, and overseeing all operational activities required to manage biosamples from sample collection at site, shipment to vendor(s) 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.
• Oversee the tracking and reporting of biosample management status/progress and address risks/issues through resolution.
• Preparing and reviewing Laboratory Manual for biomarker, bioanalytical and diagnostic testing according to the clinical study and assay requirements.
• Collaborate with internal and external team members.
• Complete other duties as assigned by Vice President, Clinical Trial Management

The base range for the Director level is $210,000-$230,000 per year and the base range for Sr. Director level is $230,000-$280,000 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.

JOB SPECIFICATIONS:

Director, Biosample Operations

• A minimum of 12 years’ experience in pharmaceutical or biotechnology drug development preferred.  15+ for Senior Director level.
• A bachelor’s degree in a relevant scientific field (e.g., biology, biochemistry, or related) is required; an advanced degree (e.g., MSc or PhD) is preferred.
• 8+ years of clinical trial management experience preferred.
• 6+ years of strong hands-on experience in clinical biosample project management preferred.
• 5+ years of line management experience 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 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.
• 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

Senior Director, Biosample Operations

• 1. A minimum of 15 years’ experience in pharmaceutical or biotechnology drug development preferred.

• A bachelor’s degree in a relevant scientific field (e.g., biology, biochemistry, or related) is required; an advanced degree (e.g., MSc or PhD) is preferred.
• 10+ years of clinical trial management experience preferred.
• 8+ years of strong hands-on experience in clinical biosample project management preferred.
• 5+ years line management experience required.
• 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 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.
• 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