Biosample Operations Associate/Senior Associate

About Oruka Therapeutics

Oruka Therapeutics is dedicated to developing innovative biologic treatments focusing on chronic skin diseases such as plaque psoriasis. Their aim is to provide patients with extended relief through highly effective therapies dosed infrequently. The company is pioneering a proprietary antibody portfolio targeting fundamental disease mechanisms in dermatologic and inflammatory conditions.

Role Overview

The Biosample Operations Associate/Senior Associate will play a critical role in managing clinical trial biospecimens throughout their lifecycle. Acting as the central communication link among investigative sites, laboratories, clinical teams, and vendors, this position ensures precise tracking, proper transfer, and documentation of samples. This role oversees the chain-of-custody and logistics from collection through laboratory transfers without handling the biological material directly, demanding close cooperation with internal and external stakeholders to maintain sample integrity, compliance, and quality.

Key Responsibilities

• Manage biospecimen activities across clinical studies, including monitoring collection, shipment, processing, storage, and transfers conducted by external labs.
• Maintain comprehensive chain-of-custody documentation and reconcile sample inventories among sites, central and specialty laboratories, and sponsor systems.
• Act as the main operations liaison for central and specialty laboratories, coordinating sample transfers required for various testing such as biomarker and genomic assays.
• Review laboratory documentation and promptly resolve discrepancies like missing samples, shipment delays, or chain-of-custody issues by collaborating with relevant parties.
• Conduct ongoing data reconciliation across lab databases, clinical systems, and sponsor tools to ensure accurate biosample records and support audit readiness.
• Collaborate with multidisciplinary teams including Clinical Operations, Translational Medicine, Regulatory Affairs, and vendors to review protocols, startup documentation, and study plans, ensuring operational feasibility for biosample management.
• Drive the development and continuous improvement of biosample processes, management tools, SOPs, and infrastructure, identifying efficiencies and enhancing data quality across growing clinical programs.

Qualifications

• Bachelor’s degree in Life Sciences or a related scientific field is required.
• Between 2 to 5 years of relevant experience in clinical research, clinical trial operations, biosample management, or laboratory settings.
• Familiarity with biospecimen workflows, clinical trial chain-of-custody protocols, and laboratory vendor coordination is preferred.
• Good understanding of ICH-GCP guidelines and clinical operational requirements.
• Strong organizational capabilities, attention to detail, multitasking ability, and effective communication skills are essential.
• Proficiency with Microsoft Office and clinical trial management or sample tracking software.
• Prior experience with biomarker, pharmacokinetic, immunogenicity, genomic, or translational medicine samples and working in biotech or pharma startups is advantageous.

Compensation and Benefits

• The position offers a competitive base salary plus equity and potential performance bonuses.
• Expected salary ranges from $104,000 to $125,000 for Associate level and $130,000 to $146,000 for Senior Associate, depending on qualifications and experience.
• The role includes the opportunity to be part of a dynamic startup culture, contributing directly to bringing novel treatments to patients.
• Additional benefits include a supportive, inclusive work environment, and opportunities for professional growth.

Location and Work Environment

The role is primarily remote with a hybrid option requiring three days onsite per week for candidates near the office in Menlo Park, CA or Waltham, MA.