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: Vice President, Head of Clinical Operations

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

Role Overview:

The head of clinical operations will provide strategic and tactical leadership for the trials within the Oruka portfolio. This includes developing the infrastructure necessary to support multiple global clinical studies that meet aggressive timelines and are in compliance with all relevant regulatory guidelines and aligned with corporate objectives.

The successful candidate will be a 'player/coach' with a track record as a leader capable of both performing clinical trial management activities as needed and leading a team of internal and external clinical operations professionals. The head of clinical operations will directly manage program level responsibilities, including startup, enrollment, cross functional collaboration in support of trials, quality oversight, timeline, and be responsible for implementing an outsourcing model that optimizes for speed and high quality. The candidate will immediately assume leadership for execution of multiple Phase 1 and 2 global trials and the associated staff.

Key Responsibilities:

Clinical Trial Management:
- Lead all operational aspects of cross functional clinical programs, including strategic planning, communication, coordination, delegation, and stepping into direct action as necessary to make sure goals are achieved on time.
- Lead the operational strategy and execution for identifying, recruiting, and retaining trial subjects.
- Function as the senior leader accountable for interfacing and managing the delivery of Contract Research Organizations (CROs), vendors, and other third parties. Drive vendors to deliver against agreed KPIs and hold them to account if they fall behind.
- In partnership with program management and all functional leads, develop clinical trial standard timelines allowing for seamless transition from startup through closeout.
Regulatory and Compliance Oversight:
- In partnership with the VPs of Clinical Development, Regulatory and Biometrics, support the preparation and submission of essential documents including protocols, investigator brochures, clinical trial applications, INDs, BLAs, and other core trial related content.
- In partnership with the VP of QA, develop and continuously improve clinical SOPs and provide oversight of clinical monitoring quality & adherence to established processes and plans in compliance with GCP.
- Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks and make appropriate trade-offs of balancing risks with study deliverables and costs.
Team Leadership:
- Demonstrated ability and track record to recruit, manage, mentor & train other operations team members in a positive and efficient manner.
- Ability to build strong, collaborative, and dynamic relationships with co-workers of diverse backgrounds and expertise.
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
- Foster a collaborative team environment focused on operational efficiency and continuous improvement.

Qualifications:

Bachelor's or Master's degree in life sciences or a related field.
15+ years of experience in clinical operations, with a focus on managing complex clinical trials.
Track record of building a clinical operations function that successfully delivered against corporate objectives previously in a small biotech decentralized setting.
Willingness to travel for corporate or trial needs including site visits, investigator meetings, scientific meetings and other locations as required. Travel will be 25-30%.
Comfortable working in a virtual team with schedule flexibility to build and maintain relationships across time zones.
Values-based leadership consistent with company's core values.

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 $305,000 to $335,000. 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.

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.

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.

Oruka Therapeutics

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