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Associate Director / Director of Clinical Outsourcing

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: Associate Director / Director of Clinical Outsourcing         

 Location: Hybrid – Waltham, MA

Role Overview: 

We are seeking a highly motivated Associate Director/Director of Clinical Outsourcing to join our dynamic, growing team as we work to set a new standard in treating chronic skin diseases. This role will be pivotal in helping support the clinical development and operational teams in their execution of the overall R&D strategy.  This position reports to the head of clinical operations.

The ideal candidate will have a strong background in outsourcing and will bring relevant experience in strategic contracting and vendor management with success progressing programs.  This individual has the ability to work collaboratively across the organization from R&D to G&A to drive value in terms of efficiency savings, cash flow improvement, creating and optimizing vendor relationships and facilitating stakeholder engagement.  A track record of driving fast paced delivery and seamless management of multiple stakeholder needs is critical. 

This individual must be a highly organized self-starter with a solid understanding of both general outsourcing principles in addition to clinical trial planning, budgeting, and the integration of activities and vendors necessary for efficient operations.

Our team values in-person collaboration, and we expect this role to work from our Waltham office at least three days per week. We’re looking for someone who shares our passion for developing innovative medicines and is eager to make a meaningful impact.

Key Responsibilities:

  • Develop and oversee RFPs, bid grids and budgets for third party vendors across a broad category of suppliers in support of R&D activities.
  • Develop tools to allow for vendor comparison and selection across vendor types.
  • Implement vendor governance tools, such as scorecards and KPIs, to track outsourcing quality and performance.
  • Ensure outsourced activities comply with regulatory requirements (e.g., GCP, FDA, EMA)
  • Partner with quality assurance to oversee audits of external vendors
  • Responsibility for negotiating Master Services Agreements, development of study level contracts, change orders, PO generation, reconciliation and closeout activities.
  • Collaborate across functions to optimize vendor relationships and ensure compliance with legal and financial guidelines including managing the accrual reporting process and associated tools. 

Qualifications:

Experience: 10+ years work experience in the industry with at least 2 years in a similar role required, preferably within an early stage public biotech/pharma company utilizing outsourced services.  Proven expertise in vendor selection, contract negotiation and management.

Education: Bachelors degree (or higher)

Skills:

  • Understanding of the clinical drug development process and associated vendor services utilized.
  • Tactical mindset with a proven track record in managing multiple projects, vendors and contracts simultaneously.
  • Excellent verbal and written communication skills, with the ability to effectively present project updates to diverse audiences.
  • Effective in a diverse, multi-functional team environment with strong interpersonal skills.
  • Strong competency developing tracking and organizational tools for managing work and workflows.

Attributes:

  • Self-motivated, action-oriented, and highly organized. Must feel comfortable working independently.
  • Collaborative, team-focused, and skilled at working across various disciplines within and outside the company
  • Operate with integrity, focus, and clarity in an environment of ambiguity to lead change and improvement.

 Preferred Experience:

  • Prior experience in small pre-revenue companies
  • Demonstrated ability to drive contract execution with aggressive timelines

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 $175,000 to $$230,000. 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

$175,000 - $230,000 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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