Oruka Therapeutics

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

Director

• 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.

Director, GMP Quality Assurance

• Lead statistical strategy for Oruka’s clinical development programs, including study design, protocol input, and statistical analysis planning.
• Plan and track biostatistics timeline and resources for assigned projects, ensuring timeline completion of quality deliverables. Proactively communicate resource needs.
• Provide statistical input for data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure that they support the protocol specified goals and statistical analyses.
• Develop statistical programs, as needed, in support of ad-hoc requests, manuscripts and presentations and provide statistical review of scientific reports and publications, ensuring appropriate and accurate data presentation.
• Write the statistical sections of regulatory documents and collaborate with Clinical and Regulatory to support Oruka’s regulatory strategy.
• Participate in the assessment, selection, and oversight of CROs within area of responsibility.
• Ensure compliance with company SOPs and working practices, industry and regulatory standards.

Director of Biostatistics

• As a key member of the Nonclinical team, this individual will be responsible for designing and overseeing nonclinical pharmacology experiments and related assays (working with CROs).
• Representing the Nonclinical function on development teams.
• Engaging in translational research efforts in support of clinical studies.
• Developing effective models using preclinical and clinical data to assess Oruka’s strategic emphasis on creating best in class treatments.
• Influencing the development of drugs and expanding the application of model-informed drug development (MIDD) while working with the clinical pharmacologist/modeler.
• Engaging with and managing outside vendors, partners and consultants as necessary, including oversight and review of assays and experiments conducted by third party vendors.
• Supporting Corporate and Business Development efforts requiring immunology expertise.
• Contributing to the development or improvement of tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
• Managing translational research efforts associated with clinical trial objectives by working with academic collaborators.
• Partnering with key stakeholders and colleagues including Development teams and leaders, interfacing closely with clinical scientists to facilitate modeling and data analysis in the non-clinical and clinical programs.
• Influencing and leading the external environment through scientific societies, publications, presentations, and collaborations.

Associate Director, Nonclinical Pharmacology

• Oversee technical operations and lead strategy discussions for late-stage CMC activities including process characterization, PPQ, licensure application, regulatory inspection, and lifecycle management of monoclonal antibody therapeutics.
• Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports, in-process-control documents, process validation master plan, and BLA Module 3 sections.
• Lead CMC meetings and ensure drug substance, drug product, analytical, clinical supply chain, quality, program management, and regulatory affairs teams are aligned with overall CMC and program strategy.
• Maintain an effective action tracker for internal and external CMC deliverables. Adapt to changing priorities to ensure corporate CMC objectives are at the forefront.
• Facilitate problem solving, action planning, and decision making within the CMC team while keeping program level stakeholders informed at regular intervals.
• Foster a strong relationship with CDMOs and consultants. Ensure the external partners are fully aligned on Oruka strategy and goals.
• Liaise with internal and external stakeholders to support timely completion of technical documents, batch records, campaign readiness, lot release, campaign reports, change controls, deviation investigations, and CAPAs.
• Partner with CDMO counterparts to oversee all CMC service, ensuring high quality work, timely delivery, and efficient meetings.
• Collaborate with manufacturing and clinical supply chain stakeholders to ensure robust clinical supply and distribution plans.
• Drive preparation and presentation of CMC content for internal and external meetings, facilitate cross-functional offsite workshops, and help organize business review meetings with CDMOs.
• Support the diligence process and contract negotiation with new CDMOs and consultants.
• Work with program managers and Finance to track budgets, contracts, and change orders.
• 20-25% travel in support of diligence process, strategy discussion meetings, and activity supervision at CDMOs.

Associate Director, CMC Lead, Late-Stage Biologics

Medical Director

• The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products.
• This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans.
• The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment.
• The role reports to the Vice President of Clinical Development.
• Drives the clinical development strategy for one or more assets.
• Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines.
• Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions.
• Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate.
• Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods.
• Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution.
• Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions.
• Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports).

Executive Medical Director, Clinical Development

Manager

• Adhere to Clinical Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
• Be a primary lead with eTMF and CTMS integration/implementation/maintenance, user training, team advisor and assist in managing oversight for the RevMed clinical trial TMFs and CTMS within timelines and designated program budgets.
• Provide strong support to establish and manage quality oversight of TMF and CTMS, including TMF metrics and KPIs.
• Partner with Clinical Study Teams, CROs/vendors and cross-functional team members to align TMF activities, as needed.
• Responsible for vendor and internal implementation and maintenance process for cataloging, filing, retrieving, storing, preserving, and protecting CTMS outputs and TMF records (paper and electronic).
• Develop successful working relationships with service providers (vendors) and CROs on TMF management including review process, ensuring TMF completeness and managing the transfer for TMF records as needed.
• Provides TMF SME audits and inspections support.
• Contributes to and implements TMF planning and strategy development, which may include evaluation of possible options for on and off-site locations.
• Use all available tools to track, analyze, oversee, and report CTMS and TMF health metrics and status to all key stakeholders.
• May be responsible for direct TMF management activities, e.g., for assigned study TMF(s).
• Responsible for contributing to risk management, contingency and scenario planning.
• Analyze and report TMF health metrics by study to be shared with stakeholders.
• Supervise, communicate system status, issues and problem solves to ensure project team goals are met.
• Actively contribute to the selection and management of eTMF, CTMS and other Clinical System solutions / vendors, including development of Requests for Proposals (RFPs).
• Anticipate obstacles, difficulties, be solution-oriented, proactively provide risk assessment and mitigation strategies to achieve goals.
• Participate in and/or co-lead departmental or interdepartmental strategic business initiatives, as well as contribute to SOP development, implementation, and training.

Trial Master File Manager

• Primary owner of QMS infrastructure and electronic systems.
• Provide oversight of document control processes, including creation, review, approval, and lifecycle management of policies, SOPs, and forms.
• Manage training program, including creation, assignment, and tracking of training; onboarding and GMP refresher training; and maintenance of training curricula.
• Administer the electronic Quality Management System (eQMS), including system implementation, validation, and management of periodic releases.
• Oversee the deviation process for compliance, ensuring appropriate documentation and adherence to procedures.
• Review and oversee CAPAs to ensure process compliance and effectiveness of corrective and preventive actions.
• Administer change control system and manage departmental changes.
• Coordinate product complaint processing.
• Review and approve GMP documentation, as requested.
• Review and support GMP investigations related to deviations, ensuring appropriate root cause analysis and CAPA development and implementation.
• 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.
• 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.

Associate Director, Quality Management System

• Serve as Global Regulatory Lead on multidisciplinary program teams for one or more investigational products.
• Develop, drive, and continuously refine global regulatory strategies aligned with program goals, development timelines, and corporate priorities.
• Provide regulatory leadership across the product lifecycle, from early development through registration planning and lifecycle management.
• Assess regulatory precedent, competitor actions, and evolving global guidance to identify strategic risks, opportunities, and options.
• Partner closely with Clinical, Clinical Operations, Nonclinical, CMC, Quality, Medical, Biometrics, and Program Leadership to ensure regulatory strategy is integrated into overall development planning.
• Lead regulatory scenario planning for key inflection points, including dose selection, indication strategy, expedited development opportunities, pediatric requirements, and regional filing considerations.
• Lead the preparation, strategy, and execution of key health authority interactions, including FDA and ex-U.S. agency meetings, scientific advice, and other formal engagements.
• Serve as primary regulatory contact for assigned programs and represent Oruka externally with health authorities, consultants, and partners, as applicable.
• Lead or oversee preparation of high-quality global regulatory submissions, including INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and components of future marketing applications, as applicable.