[Remote] Sr. Outsourcing Associate, Clinical Outsourcing
Note: The job is a remote job and is open to candidates in USA. Oruka Therapeutics is developing novel biologics aimed at improving treatment for chronic skin diseases. The Sr. Outsourcing Associate, Clinical Outsourcing will support vendor and site agreements for clinical trials, focusing on contract negotiations, budget management, and ensuring service provider performance.ResponsibilitiesSupports the preparation and tracking of site agreementsMonitors Progress of contract negotiation and execution and providers regular updates to all stakeholdersCreates effective partnerships with vendors to cultivate and support long term relationshipsIf applicable, negotiation of Clinical Trial Agreements and site budgets with US and Canadian sitesOversight of third-party negotiations of global Clinical Trial Agreements / Site BudgetsAssists with vendor governance activities as neededPartners with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performanceMaintenance of Clinical Outsourcing team Outsourcing Plans, Timelines and ProcessesEffectively communicates, develops and cultivates operationally excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programsNegotiates change orders and ensures vendors adhere to contract termsAssists 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 meetingsOversight 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 activitiesKey contributing member of the Clinical Outsourcing teamSkillsBA/BS in related discipline, a combination of relevant education and applicable job experience may be considered3-5+ years of related experience in a Biotech or Pharmaceutical organizationExposure to drug development, clinical operations and clinical outsourcingAbility to prepare/negotiate/track external provider work/change orders, etcAbility to stay organized across multiple workstreams in a fast-paced environmentExcellent negotiation skillsProvide a customer service approach to internal team membersExposure to RFI/RFP development, proposal evaluation, and contract and budget managementStrong organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectivelyExcellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint, Outlook and SmartsheetMust be a self-starterWorks effectively in a matrix cross-functional environment and can effectively influence stakeholdersGood business judgment and a strong understanding of the unique aspects of clinical financialsMust have the ability to interact with a diverse set of clinical team and functions across Oruka TherapeuticsFluent in English (verbal and written) and excellent communication skills, including the ability to understand and present budget information effectivelyHigh sense of accountability/urgencyPrior experience in small pre-revenue companiesExperience in working across a wide variety of functions supporting the drug development process and specialty service vendorsExperience in trials with varied outsourcing modelsBenefitsAn appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.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.Company OverviewOruka Therapeutics is advancing innovative biologics to redefine patient care standards in chronic skin diseases. It was founded in 2024, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 11-50 employees. Its website is https://www.orukatx.com/.