Senior Clinical Trial Manager

Position Overview

• Location Type: Remote (expectation of travel 4 days a month)
• Job Type: Full-time
• Salary: Not specified

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025. For more information, visit www.orukatx.com.

The Senior Clinical Trial Manager serves as the clinical functional lead and will lead clinical trial initiatives for Oruka's cutting-edge dermatology treatments. You will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams to advance Oruka's clinical pipeline. A Sr CTM is expected to independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe.

Requirements

• Not specified

Responsibilities

• Clinical Trial Management:
  • Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.
  • Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence.
  • Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.
  • In partnership with Program Management, develop and drive cross functional study timelines related to trial setup and execution.
• Team Leadership:
  • Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.
  • Successfully interface with Data Management, Biostatistics and Clinical Development to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines.
  • Foster a collaborative team environment focused on operational efficiency and continuous improvement.

Application Instructions

• Not specified

Company Information

• Company: Oruka Therapeutics (Nasdaq: ORKA)
• Mission: To offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year.
• Website: www.orukatx.com