Sr. Outsourcing Associate, Clinical Outsourcing

Oruka Therapeutics•Waltham, MA

1d•$130,000 - $146,000•Hybrid

About The Position

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. 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. 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.

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 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