Sr. Outsourcing Associate, Clinical Outsourcing

Oruka Therapeutics • Waltham, CA

17h • Hybrid

About The Position

Oruka Therapeutics is developing novel biologics for chronic skin diseases. The Sr. Outsourcing Associate, Clinical Outsourcing will support the business aspects of vendor and site agreements for clinical trials. This role involves contract negotiations, budget management, and oversight of service provider performance in collaboration with Clinical Operations, Biometrics, and Medical Affairs departments. The position reports to either the Sr. Dir, Clinical Outsourcing or the Associate Director of Clinical Outsourcing. Oruka is seeking passionate individuals to contribute to establishing an engaged, inclusive, and positive company culture.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Supports the preparation and tracking of site agreements.
• Monitors progress of contract negotiation and execution and provides regular updates to all stakeholders.
• Creates effective partnerships with vendors to cultivate and support long-term relationships.
• Negotiates Clinical Trial Agreements and site budgets with US and Canadian sites (if applicable).
• 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.

Benefits

• Competitive salary and benefits package.
• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior