Job Title: Sr. Outsourcing Associate, Clinical Outsourcing

Location: Remote or Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.

Role Overview

The Sr. Outsourcing Associate, 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 either the Sr. Dir, Clinical Outsourcing or to the Associate Director of Clinical Outsourcing.

Key Responsibilities

• Supports the preparation and tracking of site agreements.
• Monitors Progress of contract negotiation and execution and providers regular updates to all stakeholders
• 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
• Assists with vendor governance activities as needed
• Partners with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performance
• Maintenance of Clinical Outsourcing team Outsourcing Plans, Timelines and Processes
• Effectively communicates, develops and cultivates operationally excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programs
• Negotiates change orders and ensures vendors adhere to contract terms.
• Assists with the generation of Request for Information (RFIs), Request for Proposal (RFPs), and assists 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)
• Supports 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
• 3-5+ years of related experience in a Biotech or Pharmaceutical organization.
• Exposure to drug development, clinical operations and clinical outsourcing
• Ability to prepare/negotiate/track external provider work/change orders, etc.
• Ability to stay organized across multiple workstreams in a fast-paced environment
• Excellent negotiation skills
• Provide a customer service approach to internal team members
• Exposure to RFI/RFP development, proposal evaluation, and contract and budget management.
• Strong organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint, Outlook and Smartsheet
• Must be a self-starter
• Works effectively in a matrix cross-functional environment and can effectively influence stakeholders
• Good business judgment and a strong understanding of the unique aspects of clinical financials
• Must have the ability to interact with a diverse set of clinical team and functions across Oruka Therapeutics
• Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present budget information effectively
• High sense of accountability/urgency

Preferred Qualifications

• Prior experience in small pre-revenue companies
• Experience in working across a wide variety of functions supporting the drug development process and specialty service vendors
• Experience in trials with varied outsourcing models

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 is $130,000 - $146,000. 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.