Oruka Therapeutics

Procurement

• Assist in the development of structure and processes supporting a 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
• If applicable, negotiation of Clinical Trial Agreements and site budgets with US and Canadian sites
• Oversight of third party negotiations of global Clinical Trial Agreements / Site Budgets
• 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 and mentors junior team members

Manager, Clinical Outsourcing

Medical Director

• Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines
• Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug
• Authors and contributes to clinical and non-clinical documents required during the clinical development process
• Provides medical expertise of the therapeutic area, disease state, and potential drug effects
• Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team
• Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to help ensure optimization of the clinical development process
• Contributes to the overall clinical development strategy

Manager, Clinical Outsourcing

Director – Clinical Development