Manager/Senior Manager, 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. 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: Manager/Senior Manager, Clinical Outsourcing         

Location: Remote

Role Overview: 

The Manager/ Sr. Manager, Clinical Outsourcing is responsible for supporting business aspects of vendor and site agreements across defined clinical service providers and other outsourcing needs for current and future clinical trials. Responsibilities include contract negotiations, budget management, contract quality control through the support the Clinical Operations, Biometrics and Medical Affairs departments in the oversight of service provider performance. This position reports to the Associate Director of Clinical Outsourcing.  This position is expected to drive effective vendor selection, contract lifecycle management in partnership with multiple functions across Oruka Therapeutics to support high quality clinical trial planning and execution.

Key Responsibilities: 

• Assist in the development of structure and processes supporting the newly created Clinical Outsourcing function within Clinical Operations
• Drive the creation of complex RFI and RFP document templates
• Lead and contribute to complex outsourcing initiatives and process improvement as identified
• Creates effective partnerships with vendors to cultivate and support long term relationships
• Negotiate Clinical Trial Agreements and site budgets with US and Canadian sites
• Participates and assists with vendor governance activities as needed
• Partners with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performance
• 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
• Negotiate final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study service providers
• Negotiates change orders and ensures vendors adhere to contract terms.
• Generates Request for Information (RFIs), Request for Proposal (RFPs), and assist Clinical Operations, Biometrics or Clinical Development with the service provider selection process including bid comparison analysis, bid defense coordination and leadership of proposal review meetings
• Oversight and execution of contract lifecycle management for assigned clinical studies, vendors and/or program(s)
• Drives the identification, development, improvement and implementation of processes and tools related to outsourcing activities
• Key contributing member of the Clinical Outsourcing team

Minimum Qualifications      

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• 4-6 years of related experience in a Biotech or Pharmaceutical organization.
• Solid foundational understanding of drug development, clinical operations and clinical outsourcing
• Ability to prepare/negotiate/track external provider work/change orders, etc.
• Excellent negotiation skills
• Provide a customer service approach to internal team members
• Must demonstrate an understanding of vendor budgets and payment terms.
• Experience in RFI/RFP development, proposal evaluation, and contract and budget management.
• Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Excelle