Oruka Therapeutics

Director

• Design and implement appropriate PK/PD modeling to contribute to successful non-clinical/clinical development plans and to drive rapid development.
• Author clinical pharmacology aspects of clinical study protocols, analysis plans, reports, and related regulatory and clinical documents.
• Perform non-compartmental analyses (NCA) of our non-clinical/clinical PK data including allometric scaling.
• Influence the development of drugs and expand the application of model-informed drug development (MIDD) approaches across our portfolio. This will include the planning and execution of quantitative analyses which may include population pharmacokinetics and pharmacokinetics (PK)/pharmacodynamics (PD) exposure response.
• Engage with and manage outside vendors, partners and consultants as necessary, including oversight and review of PK/PD analyses conducted by third party vendors.
• Support Corporate modeling efforts aligned with Oruka business development needs to broaden the Oruka pipeline and strategy.
• Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
• You will partner with key stakeholders and colleagues including Development teams and leaders. You will interface closely with non-clinical scientists to facilitate modeling and data analysis in the non-clinical programs.
• Influence and lead the external environment through scientific societies, publications, presentations, and collaborations.

Associate Director – Clinical Pharmacology

Operations

• Support the operational management of clinical trial biospecimens throughout the sample lifecycle
• Serve as the primary liaison between investigative sites, central laboratories, specialty testing laboratories, clinical operations, and study vendors
• Oversee chain-of-custody processes and sample logistics from collection at clinical sites through shipment to central laboratories
• Track sample inventories and reconcile sample records between investigative sites, central laboratories, specialty laboratories, and sponsor tracking systems
• Partner closely with Clinical Operations, Clinical Development, and external vendors

Biosample Operations Associate – Senior Associate

Procurement

• 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

Senior Outsourcing Associate, Clinical Outsourcing

Compliance

• Serve as a regulatory representative on multidisciplinary program teams for one or more investigational products
• Contribute to the development and execution of global regulatory plans aligned with program objectives and development timelines
• Support regulatory planning across the product lifecycle, from early clinical development through registration planning and lifecycle management
• Evaluate regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning
• Partner closely with cross functional development team and program leadership to support development objectives and regulatory requirements
• Support the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements
• Independently manage assigned regulatory submission activities, including preparation and coordination of INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and other regulatory documents
• Monitor and interpret global regulatory requirements, guidance documents, and policy developments relevant to assigned programs

Senior Manager/Associate Director, Regulatory Affairs

• Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials conducted globally and/or domestically.
• Serve as the internal expert for monitoring strategy, site management, and risk-based monitoring approaches.
• Provide oversight and management of CROs, CRAs, and other external vendors to ensure quality, timelines, and budget adherence.
• Review monitoring plans, trip reports, metrics, and monitoring deliverables for quality and compliance.
• Partner cross-functionally with Clinical Development, Clinical Science, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
• Establish effective CRO oversight and governance processes.
• Monitor CRO performance through KPIs, metrics, and regular operational reviews.
• Escalate and resolve study conduct issues proactively.
• Ensure studies are conducted in compliance with ICH-GCP, SOPs, protocol requirements, and applicable regulations.
• Support development and review of key study documents including Monitoring Plans, Risk Management Plans, Study Oversight Plans, Clinical Trial Management Plans, and Site Management Plans.
• Help build scalable clinical monitoring infrastructure appropriate for a growing biotech company.
• Develop and refine SOPs, work instructions, templates, and monitoring processes.
• Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence.
• May directly manage CRAs and/or Clinical Trial Managers as the organization grows.
• Mentor junior clinical operations staff and contribute to team development.
• Foster a collaborative, accountable, and quality-focused culture.

Senior Manager – Clinical Monitoring Strategy & Optimization

• Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials conducted globally and/or domestically.
• Serve as the internal expert for monitoring strategy, site management, and risk-based monitoring approaches.
• Provide oversight and management of all vendors involved with clinical monitoring to ensure quality, timelines, and budget adherence.
• Develop metrics to oversee monitoring progress including central monitoring performance and protocol deviation management.
• Drive the development of the clinical monitoring plan, annotated monitoring visit reports and all training materials for CRAs.
• Identify Key Risk indicators for studies at the investigative site level and their associated oversight.
• Contribute to inspection readiness activities and support regulatory inspections and audits.
• Participate in or lead Site Qualification or Initiation visits as needed to build site relationships and monitor CRA performance.
• Help build scalable clinical monitoring infrastructure appropriate for a growing biotech company.
• Develop and refine SOPs, work instructions, templates, and monitoring processes.
• Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence.
• Implement and optimize risk-based monitoring methodologies and centralized monitoring approaches where appropriate.
• May directly manage CRAs and/or Clinical Trial Managers as the organization grows.
• Mentor junior clinical operations staff and contribute to team development.
• Foster a collaborative, accountable, and quality-focused culture.

Director – Clinical Monitoring Strategy

• Develop and execute the enterprise QC strategy to support clinical product testing, Phase 3 clinical trials, PPQ, BLA submission, and commercial launch.
• Build scalable QC systems, processes, governance, and organizational capabilities aligned with commercial-stage operations.
• Establish and maintain analytical control strategies for drug substance (DS), drug product (DP), and combination products.
• Ensure inspection readiness across QC operations, documentation, data integrity, and external partner networks.
• Serve as a strategic advisor to Quality and CMC on analytical and QC-related risks, compliance considerations, and commercialization readiness.
• Lead and provide oversight of analytical method qualification, validation, transfer, verification, and lifecycle management in alignment with ICH, FDA, EMA, and global regulatory expectations.
• Ensure all release, characterization, and stability-indicating methods are validated and commercially sustainable prior to BLA submission.
• Oversee analytical comparability strategies, method bridging activities, and technology transfers across CMOs and contract laboratories.
• Drive continuous improvement of analytical control strategies and testing programs through data trending and lifecycle management principles.
• Ensure effective governance of reference standards, critical reagents, and assay performance monitoring programs.
• Partner cross-functionally with Manufacturing, MSAT, and CMC teams to ensure QC readiness for PPQ execution and commercial manufacturing.
• Provide QC oversight for in-process, release, and stability testing supporting validation campaigns and commercial supply.
• Support continued process verification (CPV) programs through statistical trending, data analysis, and ongoing monitoring of product quality attributes.
• Ensure timely and compliant batch disposition support through robust data review and issue escalation processes.

Director, Quality Control

QA Engineer

• Provide GMP quality support and guidance for Oruka’s CMC programs, ensuring compliance with applicable GxP regulations and guidelines.
• Support the negotiation, implementation, and maintenance of quality agreements with GMP suppliers.
• Review and approve GMP documentation, including master batch records, executed batch records, analytical methods, specifications, validation protocols and reports, tech transfer documentation, stability protocols and reports, and risk-assessment documentation.
• Review and support GMP investigations related to deviations, ensuring appropriate root cause analysis and CAPA development and implementation.
• Review change controls, CAPAs, and OOS/OOT investigations in collaboration with internal and external stakeholders.
• Perform or support lot disposition activities.
• Ensure GMP quality documentation is appropriately archived and readily retrievable.
• Investigate and assess quality events such as product complaints and temperature excursions, and manage associated follow-up actions.
• Contribute to the development and maintenance of Oruka’s Quality Management System (QMS), including authoring and reviewing SOPs and quality procedures as needed.
• Review and approve clinical product labeling, ensure proper controls in place across label management lifecycle.
• Assist with the development, tracking, and reporting of GMP quality metrics and KPIs; identify trends and support continuous improvement initiatives.
• Support inspection readiness activities for both Oruka and its GMP suppliers.
• Provide GMP quality review and input for regulatory submissions and agency responses.
• Escalate quality risks and compliance issues appropriately and support risk-based decision making.
• Promote a culture of quality and continuous improvement across the organization.
• Approximately 15–20% travel (domestic and international) to GMP suppliers and Oruka offices.