Director, Clinical Operations

About Us: 

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

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.  Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.  

Job Title: Director, Clinical Operations        

Location: Hybrid – Menlo Park, CA or Waltham, MA. Candidates will be required to be in-office 3 days/week.          

We are seeking an exceptionally nimble and flexible Director of Clinical Operations who has a track record of achievement across all aspects of trial setup and execution in a fast paced small biotech with limited infrastructure and resources.  The individual will successfully lead and optimize activity across multiple studies for Oruka Therapeutics. This critical role demands a strategic leader who possesses a keen ability to "zoom in" on intricate operational details while simultaneously "zooming out" to maintain a holistic view of program progress and timelines. The successful candidate will be a proactive problem-solver, adept at navigating complexities, anticipating challenges, and implementing agile solutions to ensure our clinical trials remain on schedule and within budget. We are looking for a candidate that can demonstrate a high degree of integrity, pragmatism and is laser focused on commitment to study goals.  You should be comfortable being a ‘player/coach’ taking on tactical tasks as required in support of the program.

Key Responsibilities:

• Strategic Oversight & Agility in Clinical Study Planning, Management and Execution:
• Develop and implement strategic operational plans for clinical trials, ensuring alignment with program goals and business objectives.
• Proactively identify potential risks, bottlenecks, and deviations from timelines, and swiftly implement corrective actions with a flexible and adaptable approach.
• Demonstrate the ability to rapidly assess evolving circumstances (e.g., regulatory changes, unexpected site challenges, vendor issues) and adjust operational strategies accordingly.
• Maintain a high-level overview of all assigned clinical trials, understanding interdependencies and potential impacts on overall program timelines.
• Operational Excellence & Detailed Focus in Conducting Clinical Trials:
• Provide expert operational guidance and oversight for all phases of clinical trials, from study startup through close-out.
• Possess the ability to delve into granular operational details when necessary to identify root causes and inform strategic decisions.
• Ensure adherence to Good Clinical Practice (GCP), regulatory requirements, Standard Operating Procedures (SOPs), and company policies.
• Oversee the selection, qualification, and management of Contract Research Organizations (CROs) and other third-party vendors, ensuring their performance meets expectations and timelines.
• Maintain oversight of clinical operations budgets, including regular forecasting and internal reporting to management and finance
• Support supply chain planning and management with both clinical and non-clinical supplies for trial execution.
• Timeline Management & Proactive Problem Solving in Executing Clinical Trial Programs:
• Lead and manage clinical trial timelines, ensuring key milestones are met and proactively mitigating any delays.
• Implement robust tracking and reporting mechanisms to monitor trial progress and identify potential deviations early.
• Develop and execute contingency plans to address unforeseen challenges and keep trials on track.
• Facilitate effective communication and collaboration across cross-functional teams to drive trial progression.
• Operate as a “Hands-On” Leader &