Manager, Biosample Operations

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Strategize, execute, manage, and enhance biological sample logistics throughout Kura Oncology's Phase I–IV clinical trials.

• Provide guidance on and implement biosample strategies that comply with quality, ethical, and regulatory standards, including ICH, GCP, and GLP.

• Standardize and align biosample processes across clinical trials.

• Supervise sample collection, processing, storage, and reconciliation to optimize sample accrual and integrity.

• Examine clinical study protocols, informed consents, laboratory documents, case report forms, and laboratory scope-of-work documents.

• Ensure the ethical utilization of biosamples obtained in clinical trials.

• Plan, coordinate, and manage the entire lifecycle of patient samples from site collection to vendor shipment, testing/processing, analysis, and final disposal.

• Act as the primary liaison for project, clinical, and study teams regarding biosampling.

• Monitor and report on biosample management status and progress; troubleshoot issues and implement resolutions.

• Collaborate with both internal and external team members.

• Fulfill additional responsibilities as assigned.

⛳️ Requirements

• Bachelor's degree in science/healthcare, a nursing degree, or equivalent combined education.

• Preferred minimum of 4–6 years of clinical trial management experience.

• At least 2 years of practical experience in clinical biosample project management preferred.

• Familiarity with the drug development process.

• Ability to cultivate relationships with external partners, CROs, and biosample vendors.

• Working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Understanding of regulations and requirements for clinical trial authorization and tissue storage and transfer in major countries.

• Project management skills, encompassing risk identification and resolution proposal.

• Capacity to work independently and collaboratively in a dynamic, matrixed team environment.

• Strong analytical and problem-solving abilities; adaptable to changing priorities and deadlines.

• Excellent verbal and written communication skills.

• Effective planning, organizational, and time management skills; capable of prioritizing multiple projects.

• Competence in executing decisions made within the function.

• Ability to collaborate with cross-functional partners and support team goals.

• 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 in Microsoft Office.

🏝️ Benefits

• Competitive compensation package.

• Annual target bonus.

• Opportunities for career advancement and development.

• 401(k) plan with employer contributions.

• Generous stock options.

• Employee Stock Purchase Plan (ESPP).

• 20 days of paid time off (PTO) to start.

• 18 holidays, including summer and winter breaks.

• Comprehensive benefits package with various plans and significant employer match.

• Paid parental leave for both maternity and paternity.

• In-office catered lunches.

• Home office setup assistance.

• Lifestyle spending stipend.

• Commuter stipend for the Boston office.

• Regular employee social events, including happy hours, monthly birthday celebrations, and Kura Koffee Talks.