Clinical Operations

• Serve as an integral part of the Clinical Operations core team to drive operations efficiently including generating integrated project plans, identifying and tracking key project milestones and metrics, and monitoring budgets, invoices, and accruals.
• Provide cross-functional transparency of the clinical trial(s) progress to ensure team is efficiently progressing forward with deliverables, including deliverables from CRO and other partners.
• Organize internal and external meetings (development of agendas, minutes, and presentations)
• Manage ancillary supplies for clinical trials
• Support risk management including risk assessment, mitigation planning, and internal and external audit preparation and follow-up
• Contribute to development of clinical study plans and manuals, including version tracking and team training.
• Provide support to senior leadership in defining the deliverables on the clinical trial(s) which coincide with the expectations defined in the departmental and company goals.
• Maintain ongoing communication with team members and all stakeholders including senior leadership and external partners or vendors.
• Foster a sense of inclusion and create a shared sense of purpose.

Senior Project Manager, Clinical Operations

• Serve as business lead for one or more systems owned by Clinical Operations. Provide business support for multiple systems and applications used by Clinical operations.
• Work closely with the business owner/lead, IT systems owner/team, and relevant vendor partners. Contribute to or lead vendor management, where appropriate, dependent on owning department for vendor relationship.
• Work closely with business stakeholders inside and outside of Clinical Operations, where applicable, to understand current processes, needs, gaps, and value potential. Draft business requirements that are clear and actionable by IT/vendor partners.
• Oversee business requirements to successful implementation, including communication to IT/vendor partners and business stakeholders, perform business testing, develop processes/trainings, and where needed, refine requirements.
• Oversee use and accuracy post go-live by monitoring data/metrics, hosting office hours, and managing user inquiries (mailbox). Utilize a proactive approach to assessing accuracy, troubleshooting, and seeking user feedback.
• Maintain a repository of standard terms, definitions, and calculations utilized in respective systems (the “lexicon”). Collaborate with stakeholders on business needs, create a common understanding, and build alignment across systems.
• Serve as a system Subject Matter Expert (SME) and provide support to users and teams on various use cases. This could include providing initial training or guidance ahead of an activity; providing routine support throughout an activity; assisting in vendor management for a subset of data-focused activities or of a vendor-owned system; or, where appropriate, leading the business team on a particular activity e.g., a one-time deep-dive analysis.
• Support department-level system, data or process needs for Clinical Operations. This will include, but not limited to, management of the department SharePoint page and support on the clinical trials mailbox.
• Support Core Capabilities and broader Clinical Operations team members on system and data-related needs. This could include SME support for a particular system, compilation of information, or broader input from the system/data/process perspective based on expertise.
• Support/manage process improvement efforts, ensuring adherence to BRT standards, and all applicable regulations and guidelines.
• Review/develop business terms, BRT Working Practices, Standard Operating Procedures (SOPs), templates, training, platforms and systems to drive improvements that are advantageous to BRT.
• Represent values-based leadership consistent with BRT Core Values: courage, urgency, integrity and community.

Senior Manager, Systems and Metrics – Clinical Operations

• Provide strategic input into the global development plan
• Direct, supervise and manage all operational aspects of global clinical projects
• Ensure quality deliverables on time and within budget
• Lead large, complicated program development and/or multiple programs simultaneously
• Teach, coach and mentor direct reports

Clinical Operations Project Lead

• Provides strategic and operational leadership for one or more complex clinical studies, ensuring successful delivery through the study lifecycle (planning to execution) ensuring adherence to timelines, budgets, and quality standards.
• Develops executable study plans and milestones. Establishes and maintains clinical study timelines.
• Utilizes operational data and metrics to drive high-quality planning processes and operational execution. Monitors the same to drive overall performance and risk management.
• Maintains a comprehensive overview of study status, proactively communicating progress, risks, and mitigation strategies to stakeholders.
• Leads/partners in the development and/or QC review of key study documentation (e.g, study protocols, informed consents, monitoring plans, operational manuals)
• Drives operational initiatives key to successful study execution including but not limited to site identification/qualification, site activation strategy, site performance management, overall enrollment success (including mitigation/rescue actions as needed).
• Ensures clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines and internal quality standards.
• Supports or leads aspects of audit and inspection readiness and risk mitigation initiatives, including root cause analysis and CAPA development/closure for operational findings on assigned studies.
• Actively contributes to the advancement of department and organizational initiatives and processes.
• Leads study and/or project team(s), including effectively partnering with colleagues from other disciplines. (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators, alliance partners) to ensure seamless trial execution.
• Participate in the mentorship of clinical operations staff.
• Contributes to the development and implementation of novel clinical operations activities and methods in cell therapy.

Associate Director, Clinical Operations Study Lead

• Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget.
• Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans.
• Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy.
• Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials).
• Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies.
• Drives evidence-based site recommendations and selection.
• Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs.
• Align local and central initiatives and advise and guide on effective community engagement activities.
• Conduct co-monitoring and site identification visits, as needed.
• Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones.
• Communicates regularly on country study (ies) status and escalates unresolved issues appropriately to the Regional Clinical Operations Head, North America, Clinical Operations Asset Lead, Clinical Operations Executive Therapeutic Head, and/or Global Study Team.
• Collaborates with the Global Study Team, and when necessary, develops and executes the local implementation of the risk management plans, identifying critical issues for the country and ensuring contingencies are established and captured in the study level risk management plan.
• For in-house studies, works with the Study Start-Up Team to ensure timely submission of all regulatory, IRB and administrative submissions and helps ensure their appropriate approval.
• Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and implementation of Corrective Action Plan for assigned studies.
• Ensures that clinical data from sites are of quality and delivered in accordance with established data entry and cleaning timelines and deliverables.
• Represents country and line reports and provides the Global Study Team with actionable country-specific feedback.
• Works closely with counterparts in the Regional Clinical Operations Organization to discuss and share country best practices, and contribute to process and initiatives that improve quality and effectiveness and that provide visibility to the Regional Clinical Operations organization.
• Ensures that the Incyte Clinical Trial Management and various business intelligence and tracking systems are complete and up to date for assigned studies.
• Proactively incorporate learning and recommendation from study debriefs, best practices and lessons learned.
• Maintains oversight and ensures consistency across studies and alignment across CROs for outsourced studies.
• Makes an active contribution to therapeutic area strategy teams (i.e. Global Study Team, Asset Lead Meetings, etc) ensuring knowledge sharing of regional interest.
• Serves as an active contributor and rotating member on the Protocol Review Committee (PRC).
• Manages issues related to local invoices and provide oversight of any budget reconciliation, in collaboration with Global Clinical Study Manager and relevant departments.

Associate Director – Regional Clinical Operations

• Responsible for developing, implementing, and monitoring quality assurance and performance improvement (QAPI) programs to ensure the highest standards of patient care and regulatory compliance
• Oversee clinical outcomes, coordinate quality initiatives, ensure adherence to regulations, and collaborate with the interdisciplinary team to drive continuous improvement in patient safety and clinical quality performance
• Lead or participate in the clinic’s Quality Assessment and Performance Improvement (QAPI) program in alignment with CMS, state, and organizational standards
• Develop and implement action plans to address deficiencies and improve care delivery
• Conduct regular audits and quality reviews to ensure compliance with clinical policies & procedures
• Facilitate staff education and training related to quality improvement, patient safety, and best practices
• Collaborate with physicians, nurses, dietitians, social workers, and leadership to support evidence-based clinical initiatives
• Prepare and present quality reports to clinic leadership and governing bodies
• Ensure accurate documentation, data collection, and reporting for internal and external stakeholders
• Promote a culture of accountability, safety, and continuous improvement within the clinic
• Manage the execution and achievement of Quality key performance indicators (assigned by Quality leadership team) and other clinical initiatives, interventions and standardized education materials with clinic teams within the assigned area(s)
• Perform other related duties as assigned.

Strategic Clinical Quality Manager

• Coordinate, support, and continuously optimize clinical workflows, provider schedules, onboarding/deboarding processes, and platform troubleshooting to ensure a seamless care delivery experience.
• Review clinical dashboards for continual improvement and quality assurance.
• Assessment and distribution of weekly clinical dashboards.
• Coordinate clinicians’ calendars, ensuring alignment with patient appointments, supervision sessions, and other required or optional meetings.
• Monitor clinician schedules to ensure clinician productivity and appropriate time and calendar management practices. Identify opportunities for improvement with calendar management and share feedback and recommendations with clinicians and clinical leaders.
• Support the facilitation of patient transfers as necessary, ensuring a smooth process for both clinicians and patients.
• Troubleshoot EHR systems and business platforms to resolve technical issues efficiently.
• Provide clinicians with enrollment assistance, access troubleshooting, and account information management for our EHR.
• Provide onboarding support by training and assisting incoming clinicians.
• Close out patient charts with appropriate documentation and notification.
• Periodically review the Website Directory of providers and escalate to the Clinical Operations Supervisor if a discrepancy or an update is needed.
• Consistently evaluate workflows and Standard Operating Procedures (SOPs) to ensure alignment with organizational priorities, enhance operational efficiency, and maintain high-quality standards.
• Act as a consistent point of contact for assigned care teams, facilitate bi-annual clinician check-ins, and provide year-round guidance, resource-sharing, and operational support. Liase with patients on behalf of providers.
• Ensure providers receive an efficient, thorough, and positive onboarding and deboarding process with thoughtful collaboration of key departments and contributors (People Operations, Marketing, Supervisor of clinician, etc.)
• Conduct formal check-ins twice annually with each clinician to review updates, provide resources, and collaboratively address clinical or patient care needs.
• Lead and contribute to meaningful conversations during check-ins, advocating for patient needs and sharing actionable updates to support clinician success.
• Leverage internal dashboards and reporting tools to monitor productivity, documentation compliance, and patient reengagement opportunities.
• Develop and maintain collaborative professional relationships between operations and clinical departments.

Clinical Operations Coordinator

• Lead the end-to-end execution of clinical trials from study start-up through close-out
• Translate clinical development strategy into actionable operational plans, timelines, and budgets
• Own study-level delivery, ensuring trials are conducted on time, within budget, and in compliance
• Identify risks early and drive mitigation strategies to maintain program momentum
• Lead day-to-day oversight of CROs and external vendors, ensuring performance, quality, and accountability
• Define and track KPIs and deliverables, escalating issues as needed
• Partner with VP and cross-functional stakeholders on vendor selection and governance
• Act as the primary escalation point for operational challenges
• Drive alignment across Clinical Development, Translational & Research, Regulatory, and CMC / Manufacturing
• Ensure seamless communication of timelines, risks, and decisions across teams
• Build and implement study-level processes, tools, and tracking mechanisms
• Contribute to the development of broader clinical operations infrastructure in partnership with the VP
• Ensure study execution aligns with ICH-GCP, regulatory requirements, and internal SOPs
• Oversee TMF quality and completeness at the study level, ensuring inspection readiness
• Support audits and inspections in collaboration with Quality and VP Clinical Operations
• Provide direction and mentorship to clinical operations staff (e.g., CTAs, CTMs) as applicable
• Foster accountability, prioritization, and strong execution across the study team
• Contribute to hiring and scaling of the clinical operations function

Director/Sr. Director, Clinical Operations

• Co-own and execute the early development strategy for the immunology portfolio with the Head of TMed Immunology
• Provide comprehensive strategic planning and operational oversight for immunology clinical programs and trials to ensure efficient, timely execution against milestones
• Ensure appropriate resources, competencies, and partnerships are in place to meet objectives
• Serve as the deep subject matter expert for early immunology clinical operations
• Critically review strategy and clinical program documents (development plans, investigator’s brochures, protocols, etc.), providing scientific and operational insight to ensure best path forward
• Partner with Business Development and Licensing to evaluate internal and external opportunities that align with portfolio strategy
• Actively participate in annual and quarterly planning cycles: identify risks, develop and execute mitigation plans, and track performance metrics and outcomes
• Ensure immunology data integrity across organization (Book of Business, CTMS, etc.)
• Build and sustain strong cross-functional relationships (country operations, clinical supplies, data management, regulatory, etc.) across departments, divisions, and geographies
• Foster the people pipeline: Attract, coach, mentor, and retain talent; provide performance management support; act as ‘player-coach’ to enrich group skillsets
• Represent TMed on enterprise strategic initiatives and lead continuous-improvement efforts that increase program efficiency and scientific impact
• Serve as a member of the TMed U.S. Clinical Operations leadership team and contribute to shaping department strategy

Translational Medicine Clinical Operations Lead – Immunology

• Drive the AI-native Development Operations strategy and roadmap, anchored to measurable clinical trial outcomes.
• Lead prioritization for AI opportunities across Development Operations in line with the AI-native Development Operations strategy and R&D priorities.
• Continuously scan the external landscape for emerging AI capabilities, frontier tools, vendor offerings, and new ways of working, translating relevant developments into clear implications for Development Operations strategy, portfolio priorities, and build-buy-partner choices.
• Define the build-buy-partner approach for each priority capability, including vendor and partner evaluation where needed, balancing speed, differentiation, risk, cost, and long-term platform value.
• Build and defend business cases with clear ROI, payback logic, and success criteria; enforce stage-gate discipline, including the decision to stop or reshape initiatives that do not demonstrate value.
• Shape the deployment strategy and roadmap with enterprise AI, technology, data, security, regulatory, and quality teams to ensure scalable and compliant delivery using shared foundations rather than one-off point solutions.
• Drive cross-functional alignment and endorsement for the AI-native Development Operations strategy across the enterprise.
• Partner with leaders across R&D to identify priority workflow bottlenecks, define measurable outcomes, and shape AI-native capabilities.
• Lead 0-to-1 incubation for priority opportunities: frame hypotheses, use AI-native development tools to run hands-on experiments with technology teams and business SMEs, and define the evidence required to scale, reshape, or stop.
• Define adoption strategy for priority AI-native capabilities, including workflow redesign, user readiness, and change interventions required for scaled deployment.
• Stakeholder Management: Leaders across R&D to identify priorities, secure sponsorship and align on value. Leaders across enterprise AI, technology, security, and quality teams to enable scalable deployment. Strategic relationships with external vendors, consulting partners and technology providers to assess capabilities, shape partnerships and deliver value. Frontline users across Development Operations to ensure solutions solve real problems and value is realised at scale.

AI Strategy Director – Global Clinical Development Operations

• Lead and manage and provide strategic input on one or multiple clinical studies and demonstrate thorough knowledge of clinical operations’ project management. Lead cross-functional clinical study team to support clinical study delivery.
• Evaluates, selects, and ensures appropriate oversight of CROs and other external vendors.
• Ensures clinical trials are executed according to scope of work, budget, timelines, and KPIs.
• Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support corporate goals.
• Identify risks and propose solutions to facilitate clinical studies.
• Develop and demonstrates accountability for the management of study budgets through review and approval of contracts and/or work order changes; manages budget forecasting and accruals in collaboration with finance.
• Oversee and manage the creation, maintenance, QC and close out of TMF activities.
• Ensure appropriate oversight of enrollment, site activation and data collection milestones.
• Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
• Collaborate with the Clinical Data Manager to ensure timely and efficient database lock.
• Participate in data review and reconciliation efforts.
• Mentor junior team members by delegating study related responsibilities, overseeing, and supporting development plans.
• Lead or co-lead department initiatives to support an expanding organization.
• Travel may be required (10% – 15%).

Associate Director, Clinical Operations

• Manage multiple aspects of clinical studies working under the guidance and direction of the Clinical Program Lead.
• Accountable for the delivery of project(s) to achieve agreed timelines, scope, quality, and budget.
• Perform oversight of CRO and auxiliary vendors; identify risks and broker solutions.
• Provide support and oversight managing the creation, maintenance and close out of TMF activities.
• Ensure appropriate escalation of enrollment, site activation and data collection milestones.
• Support the clinical team to ensure the completeness of clinical protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
• Ensure site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are adhered to.
• Support database lock by ensuring appropriate oversight of sites and by participating in data review/reconciliation efforts.
• Coordinate with Clinical Supply Chain regarding drug forecasting and supply of drug product to sites.
• Establish and maintain effective communication and collaboration with functional area peers to meet study/program objectives and support goals.
• Lead or co-lead department initiatives to support an expanding organization.
• Travel may be required (10% – 15%).

Manager, Clinical Operations

• Leading and executing complex clinical trial contracts and budget negotiations with investigative sites, CROs and vendors
• Partnering with Clinical Operations leadership to develop and deliver contracting and budgeting strategies across programs and portfolios
• Providing strategic input into study feasibility, start up planning and early budget development
• Ensuring contracts and budgets comply with company policies, regulatory standards and regional requirements
• Collaborating closely with Clinical Operations, Finance, Legal and study teams to drive timely execution and approvals
• Identifying financial, operational and regional risks and proactively proposing mitigation strategies
• Tracking contract and budget performance, reporting trends and key metrics
• Driving continuous improvement initiatives to enhance efficiency, consistency and best practices
• Acting as a subject matter expert on contract templates, budget models and industry standards

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