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Director of Clinical Operations

Waltham, Massachusetts, United States

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 of Clinical Operations   

Location: Waltham, MA-Hybrid on-site 3 days a week

Role Overview:

As the Director of Clinical Operations, you will be responsible for providing strategic leadership and detailed operational management oversight of one or more programs.  You should be comfortable being hands on, managing all aspects of a study or studies including building relationships with trial sites and fostering relationships with CROs and third-party vendors.  You have an innate approach that is centered on integrity, collaboration, and organization and a proven track record of operational execution in a small company environment.  You thrive in a fast-paced, innovative environment, while remaining flexible, proactive, resourceful, and efficient.  There is an expectation for hybrid working, including 3 days/week in our Waltham office and the remaining days out of your home-based office.

Key Responsibilities:

  • Strategic Leadership: Develop and implement high-level Clinical Operations and study-specific strategies aligned with the clinical development plan. Analyze complex issues to quickly develop relevant and realistic plans and recommendations to implement. Monitor vendors and track metrics ensuring operational success and delivery on time in support of the functional and corporate goals.
  • Clinical Operations Oversight: Be the primary driver of all clinical study related activities, timelines, actions and plans. Be both an individual contributor in addition to clinical operations program leader.  Ensure communication and understanding of risks and challenges are clear to functional and program leadership.  Lead the development of the clinical study program, including critical path activities, enrollment projections, interdependencies, and milestones. Be a resource for junior staff, providing mentoring and leadership support. 
  • Cross-functional Collaboration: Manage cross-functional relationships with internal and external stakeholders utilizing excellent matrix management skills and written and verbal communication skills.  In collaboration with clinical development, contribute to essential document development and regulatory filing preparation.

Qualifications:

  • BS/BA – health/science related field preferred and a minimum 10-12 years relevant industry experience
  • Excellent organizational, communication, interpersonal, and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
  • Demonstrated ability to work independently as well as in a team environment and seek resources as necessary
  • Ability to foster effective relationships with vendors, investigators and colleagues
  • Ability to contribute technical expertise to the various aspects of the clinical trial process
  • Proficiency in study monitoring activities
  • Knowledge of the infrastructure and operational characteristics of CROs and centralized services.
  • Demonstrated effective personnel management skills
  • Experience across Phase 1 through 3 clinical trial execution with a strong preference for first-in-human or early phase global experience
  • Dermatologic drug development experience is a plus
  • Must be willing to travel domestically and internationally up to 10-15% 

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, who will work in Waltham, MA, is $200,000-225,000. 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. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

Job Location:

  • Position is hybrid, based in Waltham, MA. Candidates will be required to be in-office 3 days/week.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Salary Range for the Role

$200,000 - $225,000 USD

What We Offer:

  • A chance to be part of a vibrant small-company culture where your work can directly impact bringing new medicines to patients.
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.

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