Associate Director, Clinical Outsourcing

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, Clinical Outsourcing         

Location: Remote or Hybrid – (Waltham, MA). Candidates will be required to be in-office if located near Waltham, MA 3 days/week.          

Role Overview: 

The Associate Director, Clinical Outsourcing is responsible for vendor relationship management and supporting business aspects of vendor agreements across defined clinical vendors and other outsourcing needs for current and future clinical trials. Responsibilities include vendor governance, vendor identification, RFIs/RFPs, service provider selection, contract negotiations, budget management and support the study team stakeholders and/or operational leads in the oversight of vendor performance. This position reports into the Head of Clinical Outsourcing.  This position is expected to drive effective vendor selection, management and oversight in partnership with study teams and Oruka functions to support high quality clinical trial planning and execution.

Key Responsibilities: 

• Lead Outsourcing and Vendor Manager at program level to support long term outsourcing strategy in partnership with all Clinical Operations leads
• Manage the contract lifecycle for assigned program(s) in close collaboration with finance and legal
• Create partnerships with vendors to support long term relationships
• Leads the team to develop thorough scope of work documents and expectations to ensure high quality work that meet key deliverables
• Effectively builds budget templates and actively negotiates rates with CROs to ensure fiscal responsibility and transparency
• Manages corporate risk by working with legal to develop contracts that ensure services are completed with high quality and within budgets and timelines
• Effectively communicates, develops and cultivates operationally excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programs
• On an as needed basis, assess Master Services Agreements for areas of operational or business risk and negotiate improved language in partnership with legal through MSA Amendments. Negotiates final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study vendors
• Negotiate Clinical Trial Agreements (CTAs) and Site Budgets with Institutions in the United States and Canada.
• Partner with CRO to oversee CTA and Site Budget country template development as well as negotiations with Institutions on a global scale
• Track contracted to actual investigator grant budgets across all Clinical Programs
• Work through complex contracting scenarios to support operational execution of dermatology trials.
• Generates Request for Proposal (RFPs) and budget grids/trackers for clinical trials and assist functional Vendor Lead with the service vendor selection process including bid comparison analysis
• Leads and coordinate bid defenses and proposal review meetings
• Assists Clinical Operations Leadership team and Finance with month-end and budget/forecasting needs, such as accruals, project budgets, etc.
• Facilitates and executes vendor governance meetings and reviews
• Supports management with audits of contract and sourcing records to ensure accuracy and completeness.
• Drives the development, improvement and implementation of assigned processes and tools related to outsourcing activities
• Key contributing member of the Clinical Oper