Oruka Therapeutics

Procurement

• 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, 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 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.

Manager/Senior Manager, Clinical Outsourcing

Clinical Research

• The Clinical Scientist plays a key role in the execution and operational support of clinical trials, assisting in the collection and review of clinical data to ensure study success.
• This role involves supporting protocol development, study implementation, data review, and documentation preparation to align with clinical development goals.
• The Clinical Scientist collaborates closely with cross-functional teams to ensure the generation of high-quality clinical data.
• Additionally, they work closely with the Medical Director, Clinical Development to execute key tasks.
• Contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods.

Clinical Scientist, Clinical Development

Research Scientist

• Lead external method development, optimization and qualification/validation efforts across liquid chromatography, capillary electrophoresis, spectrophotometric and bioassay (among others) for release and stability testing of clinical trial materials.
• Manage multiple non-GMP and GMP stability studies for drug substance (DS) and drug product (DP) batches for multiple programs.
• Leverage stability data to project shelf-life of both DS and DP supply through trending analysis.
• Develop strategies to establish characterization and comparability packages across various DS/DP lots.
• Support process and manufacturing teams towards implementation of relevant analytical methods.
• Work closely with cross-functional stakeholders (QA, Regulatory, Clinical Supply Chain) for shelf-life extension of clinical material to support ongoing clinical trials.
• Partner with internal and external stakeholders to justify and establish DS/DP protocols and specifications.
• Work with CDMO partners to perform root cause analysis and investigations to support OOS/OOT results that may arise during stability studies.
• Contribute to IND/BLA sections pertaining to analytical methods, stability studies, characterization and analytical comparability.
• Lead the diligence process to select clinical and commercial CDMO vendors.
• Partner with operations, legal, and finance groups to finalize confidentiality, master service and contractual agreements.
• 20-25% travel in support of diligence and campaign execution at the CDMOs.

Principal Scientist – Analytical Development, Tech Ops, Biologics

Manager

• Responsible for the oversight of all data management CRO activities supporting Oruka Therapeutics, Inc clinical programs from database start-up through database lock and CSR/submission.
• Primary point of contact with the DM CROs, 3rd party vendors and internal study teams.
• Develop study timelines in conjunction with the internal team and DM CRO and ensure all DM related deliverables are met.
• Oversee the development of the clinical database (DB), including user requirements, eCRF, edit rules/checks, data validation and User Acceptance Testing.
• Oversee the development of key data management documents such as case report forms (CRF), data validation specifications, manual data review guidelines, CRF Completion Guidelines, programable edit checks, Data Management Plans (DMP) and other related documents. Ensures compliance with these study documents.
• Participate in the development of other study related systems such as ePRO/eCOA and IVRS study specifications.
• Oversee all study related data cleaning activities including reconciliation with all external databases.
• Responsible for the review and accuracy of the study statement of work, RFPs, budgets, and Change Orders.
• Work with the CRO to ensure the clinical data within EDC and all external data (ex: ePRO; Labs; EKG) are in good quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock.
• Work within the Biometrics group to create and implement oversight listings, reports, programing checks and/or patient profiles.
• Responsible for the internal review of all data regularly during study conduct leading to database lock.
• Responsible for the maintenance of Oruka internal Data Review Log and working with DM vendor to get all issues resolved.
• Participate in the review of various Clinical research documents (e.g. Protocols, Safety Monitoring Plans, Communication Plans).
• Responsible for the review of all DM CRO metrics, reports and reconciliation logs to ensure quality and escalation/resolutions of issues are done in a timely matter.
• Develop, tracks, analyze and report, as applicable, on data management performance metrics from study start to database lock.
• Trouble shoots any data-related issues and finds immediate solutions.
• Create, present, and implement lessons learned related to DM activities for process improvement.
• Assist/participate in the preparation and oversight of study audits/inspections both internal and external.
• Responsible for the oversight of all DM documents in the TMF (Trial Master File) or eTMF.
• Attend and present during Study Kick Off meetings and/or Investigator Meetings
• Responsible for creating and maintaining meeting minutes for internal DM lead meetings/decision logs.
• Provide input during the development and/or review of Data Management SOPs, Work Instructions and templates/standards incorporating the industry’s best practices and any applicable Regulatory guidelines and requirements.

Manager/Senior Manager, Clinical Outsourcing

Clinical Scientist, Clinical Development

Principal Scientist – Analytical Development, Tech Ops, Biologics

Clinical Data Management Manager