Manager/Sr. Manager, Clinical Outsourcing

Job Title: Manager/Sr. Manager, 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 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, and 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.  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 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

Minimum Qualifications  

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• 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
• Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint, Outlook and Smartsheet
• Must be a self-starter who works with limited supervision
• 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   

• Preferred experience in RFI/RFP development, proposal evaluation, preparation/negotiation of clinical contractual agreements, manage contract lifecycle and budget management for assigned clinical project/operations
• Experience in working across a wide variety of functions supporting the drug development process and specialty service vendors
• Experience in trials with complex 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 the Manager level is $146,000 – $161,000 and for the Senior Manager level is $161,000 - $187,000. 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.

Location:

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

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.