Manager, Biosample Operations

Job not on LinkedIn

🔥 13 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $150k - $178k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

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Kura Oncology, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🏥 Healthcare

🍽️ Food & Beverage

💼 Consulting

💰 $125M Post-IPO Debt on 2022-11

Healthcare • Food & Beverage • Consulting

Kura Oncology, Inc. is a biopharmaceutical company specializing in the discovery and development of precision medicines designed to target cancer cells selectively. The company focuses on creating novel therapies aimed at improving patient outcomes in areas with significant unmet medical needs, such as head and neck cancer, lung cancer, and acute leukemias. Kura Oncology conducts clinical trials for its pipeline products, including Ziftomenib and Tipifarnib, to find effective treatments for conditions like Acute Myeloid Leukemia and Head and Neck Squamous Cell Carcinoma. The company is committed to the promise of precision oncology, striving to improve the quality and longevity of life for cancer patients by combining innovative therapies with existing standards of care.

📋 Description

• Plan, implement, manage, and drive biological sample logistics within Kura Oncology Phase I–IV clinical trials • Advise on and deliver biosample strategy in accordance with quality, ethical, and regulatory standards, including ICH, GCP, and GLP • Standardize and harmonize biosample activities across clinical trials • Oversee sample collection, processing, storage, and reconciliation to maximize sample accrual and quality • Review clinical study protocols, informed consents, laboratory documents, case report forms, and laboratory scope-of-work documents • Ensure ethical use of biosamples collected in clinical trials • Plan, coordinate, and oversee the lifecycle of patient samples from site collection through vendor shipment, testing/processing, analysis, and final disposition • Serve as the primary point of contact for project, clinical, and study teams on biosampling • Track and report biosample management status and progress; address issues and resolutions • Collaborate with internal and external team members • Complete other duties as assigned

🎯 Requirements

• Bachelor’s degree in science/healthcare, a nursing degree, or equivalent combined education • Minimum of 4–6 years of clinical trial management experience preferred • 2+ years of hands-on clinical biosample project management experience preferred • Understanding of the drug development process • Ability to build relationships with external partners, CROs, and biosample vendors • 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 team environment • Analytical and problem-solving skills; ability to adapt to changing priorities and deadlines • Excellent verbal and written communication skills • Planning, organization, and time management skills; ability to prioritize multiple projects • Ability to execute decisions made within the function • Ability to collaborate with cross-functional partners and support team objectives • 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 with Microsoft Office

🏖️ Benefits

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