---
title: 'Director, Clinical Operations at Oruka Therapeutics'
canonical: 'https://feeny.ai/job/director-clinical-operations-oruka-therapeutics-waltham-massachusetts-dmf2nbp3y8nt'
type: 'job'
last_seen: '2026-09-09'
---

# Director, Clinical Operations at Oruka Therapeutics

- **Company:** Oruka Therapeutics
- **Location:** Waltham Massachusetts, United States
- **Compensation:** $213k–$240k
- **Work type:** remote
- **Posted:** 2026-05-29
- **Last confirmed live:** 2026-09-09
- **Apply:** https://job-boards.greenhouse.io/oruka/jobs/5236048008

## Job description

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. For more information, visit [www.orukatx.com](http://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: Waltham, MA  Hybrid – onsite 3 days/week required

Reports To: Vice President, Clinical Operations

Role Overview:

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 & Develop Teams in a Fast-Paced Environment:
- We need a hands-on leader who can contribute individually to deliverables and meet deadlines to hit ORUKA milestones.
- Foster a culture of accountability, continuous improvement, and proactive problem-solving within the clinical operations group.
- Represent Clinical Operations in internal and external meetings, contributing to strategic discussions and decision-making.

Qualifications:

- BA/BS required in a scientific/medical field preferred
- A minimum of 10+ years of experience in managing global clinical trials at all stages of development
- Experience in immunological and dermatologic disease areas welcome
- Capable of managing direct reports from afar and study team members across multiple time zones and cultures
- Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities
- Demonstrated successful management and oversight of CROs and other service providers
- Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings
- Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities
- Strong vendor management experience required
- Experience in the management and maintenance of EDC, CTMS, IRT, ePRO, etc.
- Experience with Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure
- Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities
- Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations
- Strong project management experience and skills is preferred
- Demonstrate strong leadership, collaboration and cross-functional management skills, ability to multi-task in a dynamic and fast-paced environment
- Strong interpersonal, negotiation, influencing, problem-solving skills
- Excellent written and verbal skills required
- Willing to travel domestically and internationally up to 25% of the time
- Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
- Strong computer and database skills
- Clear and concise oral and written communication skills
- Excellent organizational skills and experience prioritizing conflicting demands
- Critical thinking, problem solving, ability to work independently.
- Consistently operate with urgency, clarity and conciseness
- Communicate effectively and articulate complex ideas in an easily understandable way

Compensation:

- An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
- The anticipated salary range for candidates is $213,000 - $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.

Location: Waltham, MA  Hybrid – onsite 3 days/week required Salary Range for the Role $213,000—$240,000 USD

What We Offer:

- 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 where everyone is encouraged to bring their authentic selves to work.
- Opportunities for professional growth and development.

## About Oruka Therapeutics

## Company Overview
- **One-liner**: Oruka Therapeutics is a clinical-stage biotechnology company developing potentially best-in-class monoclonal antibodies with extended half-lives to transform the treatment of psoriasis and other chronic inflammatory skin diseases by enabling high rates of complete disease clearance with as few as one or two doses per year.
- **Entity Type**: Public (Nasdaq: ORKA)
- **Headquarters**: Waltham, Massachusetts, United States (with a second office in Menlo Park, California)
- **Founded**: Not publicly available
- **Founders**: Not publicly available (the company was formed as a spinout of Paragon Therapeutics, which discovered its antibody pipeline)

## Core Business
- **Primary industry**: Biotechnology – dermatology and inflammatory disease therapeutics
- **Target customers**: Patients with plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and other inflammatory conditions; physicians and healthcare providers; payers and health systems
- **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.”* [orukatx.com](https://orukatx.com/)

## Products & Services
- **ORKA-001**: An investigational monoclonal antibody targeting IL-23p19, engineered for extended circulation time. Designed as a potentially best-in-class therapy for moderate-to-severe plaque psoriasis, with the potential for dosing once or twice per year. Currently in Phase 2b clinical trial (EVERLAST-B). [orukatx.com](https://orukatx.com/our-pipeline/)
- **ORKA-002**: An investigational monoclonal antibody targeting IL-17A/F, also engineered for half-life extension. Aimed at psoriasis, psoriatic arthritis, and hidradenitis suppurativa, with potential dosing two to three times per year. Currently in Phase 1/2. [orukatx.com](https://orukatx.com/our-pipeline/)
- **ORKA-003**: A preclinical sequential combination regimen of ORKA-002 and ORKA-001, designed to deliver rapid responses with an ideal maintenance profile. [orukatx.com](https://orukatx.com/our-pipeline/)
- **ORKA-021**: Preclinical stage candidate (details not fully disclosed). [orukatx.com](https://orukatx.com/our-pipeline/)

## Market Standing
- **Valuation/Market Cap**: Not publicly available at this time (company went public via IPO; market cap fluctuates daily). Latest financial data should be obtained from SEC filings.
- **Key Metric**: As a clinical-stage public company, Oruka has no approved products yet. Funding and operational runway are funded by its IPO proceeds; exact amounts not provided in search results.
- **Notable Investors/Partners**: Discovery and engineering partner: Paragon Therapeutics (also parent of Apogee Therapeutics and Spyre Therapeutics). Investor base includes public market shareholders post-IPO.
- **Growth Signals**: 
  - Two co-lead programs advancing through clinical trials (Phase 1 data expected; Phase 2 ongoing).
  - Team expanding rapidly, with multiple job openings across scientific, clinical, and corporate functions.
  - Dual-location offices (Boston area and Bay Area) to attract top biotech talent.

## Competitive Advantages
- **Advanced antibody engineering**: Incorporates half-life extension technology (e.g., YTE mutations) to dramatically prolong circulation time, aiming for the longest dosing intervals in the class (1–2 doses per year vs. standard 4–12 times per year).
- **Proven mechanisms**: Targets IL-23p19 and IL-17A/F—validated, blockbuster pathways in psoriasis—but with enhanced pharmacokinetics to maximize efficacy and patient convenience.
- **Discovery engine**: Pipeline originated from Paragon Therapeutics, a proven antibody engineering shop that also spawned Apogee and Spyre, indicating a repeatable model for creating best-in-class molecules.
- **Focus on complete clearance**: Emphasizes “complete disease clearance” (e.g., PASI 100) as a goal, not just improvement—a higher bar than many current treatments.

## Strategic Focus
- **Near-term**: Generate Phase 1 safety and pharmacokinetics data for ORKA-001 and ORKA-002; advance EVERLAST-B (Phase 2b for ORKA-001) and ORCA-SURGE (Phase 2 for ORKA-002); initiate trials in additional indications (psoriatic arthritis, hidradenitis suppurativa).
- **Long-term**: Build a fully integrated biopharmaceutical company capable of commercializing novel biologics, potentially expanding beyond dermatology into other inflammatory diseases.
- **Organizational growth**: Aggressively hiring across all functions (clinical development, medical affairs, regulatory, CMC, finance, BD, etc.) to scale from early-stage to late-stage organization.

## Why Work Here
- **Mission-driven**: A chance to directly impact millions of patients living with chronic skin diseases—offering the potential for life-changing freedom from disease.
- **Startup culture with public-company resources**: Small, nimble team (“wear multiple hats”) but with the backing of a Nasdaq listing, equity grants, and competitive compensation.
- **Flexible work environment**: Remote-first policy with hybrid options (3 days/week) if located near Waltham, MA or Menlo Park, CA offices. [greenhouse.io](https://job-boards.greenhouse.io/oruka/jobs/5202407008)
- **Compensation & benefits**: Competitive base salary (e.g., Senior Scientific Communications Manager salary range $161k–$187k), equity, performance bonus, and professional development opportunities. [greenhouse.io](https://job-boards.greenhouse.io/oruka/jobs/5202407008)
- **Team culture**: Described as “vibrant startup culture,” “supportive and inclusive,” with emphasis on bringing “authentic selves to work.” Opportunities for growth in a fast-moving, high-autonomy environment.
- **Top-tier location**: Offices in both the Boston/Cambridge biotech hub and the Bay Area, giving employees access to two of the strongest life science ecosystems.

## Sources
1. [orukatx.com – Home](https://orukatx.com/)
2. [orukatx.com – Who We Are](https://orukatx.com/who-we-are/)
3. [orukatx.com – Pipeline](https://orukatx.com/our-pipeline/)
4. [orukatx.com – Join Us](https://orukatx.com/join-us/)
5. [greenhouse.io – Senior Scientific Communications Manager job posting](https://job-boards.greenhouse.io/oruka/jobs/5202407008)

## Other roles at Oruka Therapeutics

- [Sr. Associate/Manager Project Management & Operations](https://feeny.ai/job/sr-associate-manager-project-management-operations-oruka-therapeutics-waltham-vkjrt9srrzv7) — Waltham Massachusetts, United States
- [Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization](https://feeny.ai/job/senior-manager-associate-director-clinical-monitoring-strategy-optimization-fz8n0jqr0913) — Menlo Park California, United States / Waltham Massachusetts, United States
- [Associate Director, Regulatory CMC (Biologics)](https://feeny.ai/job/associate-director-regulatory-cmc-biologics-oruka-therapeutics-waltham-8tegt1p70qg9) — Waltham Massachusetts, United States
- [Associate/Sr. Associate - CMC Project Management & Operations](https://feeny.ai/job/associate-sr-associate-cmc-project-management-operations-oruka-therapeutics-nxqjhp0d3ycd) — Waltham Massachusetts, United States
- [Associate Director/Director, Clinical Pharmacology](https://feeny.ai/job/associate-director-director-clinical-pharmacology-oruka-therapeutics-remote-mszse4yzs07a)
- [Administrative Assistant](https://feeny.ai/job/administrative-assistant-oruka-therapeutics-waltham-w7s67gb88efv) — Waltham, MA
- [Sr. Manager/Associate Director, Regulatory Affairs](https://feeny.ai/job/sr-manager-associate-director-regulatory-affairs-oruka-therapeutics-menlo-park-810qkwnjxqp4) — Menlo Park, CA / Waltham, MA
- [Director of Biostatistics](https://feeny.ai/job/director-of-biostatistics-oruka-therapeutics-remote-v8hjmy2gjd5v)
- [Medical Science Liaison-Southeast](https://feeny.ai/job/medical-science-liaison-southeast-oruka-therapeutics-remote-0tptf8yxr814)
- [Medical Science Liaison-South Central](https://feeny.ai/job/medical-science-liaison-south-central-oruka-therapeutics-remote-4j3fngt21w29)