Senior Clinical Trial Manager

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 engineered by Paragon Therapeutics and targeting the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.

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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.

The Senior Clinical Trial Manager serves as the clinical functional lead and will drive clinical trial initiatives for Oruka’s cutting‑edge dermatology treatments. The role requires independent management of clinical trials, ensuring compliance, regulatory alignment, and operational efficiency while collaborating with cross‑functional teams to advance Oruka’s clinical pipeline. A Sr CTM is expected to effectively plan and execute studies, ensuring quality deliverables within specified budgets and timelines.

• 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.
  • Develop and drive cross‑functional study timelines related to trial setup and execution.
  • Drive the internal study team, ensuring alignment, risk management, and coordination across all participating functions.
  • 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.
• Regulatory and Compliance Oversight
  • Ensure that clinical trials are conducted in compliance with all applicable regulations, including FDA, EMA, and ICH‑GCP guidelines.
  • Support preparation and submission of clinical trial applications, including INDs, NDAs, and other regulatory documents.
  • Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.
• Budget and Resource Management
  • Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.
  • Monitor and control trial costs to ensure alignment with project forecasts and company objectives.
  • Negotiate contracts and budgets with clinical vendors and investigators.
• Vendor and Site Management
  • Oversee the selection and management of clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.
  • Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high‑quality data collection and trial conduct.
  • Perform risk assessment and management, addressing issues proactively to mitigate operational issues.

• Bachelor’s or Master’s degree in life sciences or a related field.
• 7+ years of experience in clinical operations, with a focus on managing complex clinical trials.
• Expertise in GCP and regulatory requirements.
• Strong leadership and team management skills.

Competitive base salary in the range of $155,000–$180,000 USD, augmented with equity and performance‑related bonuses. Final compensation will be determined based on experience, qualifications, and other factors.

Hybrid – Waltham, MA. Candidates will be required to work in‑office 3 days per week.

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment encouraging authenticity.
• Opportunities for professional growth and development.

As set forth in Oruka Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.