Clinical Operations

• Create, manage, and maintain integrated study schedule in MS Project, including Key Event Maps, Roadmaps, and critical path visualization aligning in Planisware.
• Assure Clinical timelines in Planisware align to MS Project schedule and coordinate the integrated clinical plan with Clinical Development Team project plans.
• Ensure proper resource demand is reflected.
• Develop scenarios in Planisware for budget, timeline, and FTE forecasting, while generating situational operational scenarios.
• Collect, consolidate, and report financial, timeline and resource data for governance approvals and external funding partnerships.
• Manage scope control, FTE and Out of Pocket variances.
• Document key decisions, actions, risks, issues, and lessons learned, as well as maintain trial governance documentation.
• Ensure risks are captured and monitored.
• Ensure budgets are effectively managed and forecasts adjusted to reflect current thinking.
• Drive and facilitate after action review meetings and results are documented.
• Work with the team to assess and remediate impact to scope, budget, timelines.
• Provide support for team-based reporting.
• Mentor & support onboarding of new team members, particularly those in Trial Management.

Senior Clinical Project Manager, Analyst

• Create, manage, and maintain integrated study schedule in MS Project, including Key Event Maps, Roadmaps, and critical path visualization aligning in Planisware.
• Assure Clinical timelines in Planisware align to MS Project schedule and coordinate the integrated clinical plan with Clinical Development Team project plans.
• Ensure proper resource demand is reflected.
• Develop scenarios in Planisware for budget, timeline, and FTE forecasting, while generating situational operational scenarios.
• Collect, consolidate, and report financial, timeline and resource data for governance approvals and external funding partnerships.
• Manage scope control, FTE and Out of Pocket variances.
• Document key decisions, actions, risks, issues, and lessons learned, as well as maintain trial governance documentation.
• Ensure risks are captured and monitored
• Ensure budgets are effectively managed and forecasts adjusted to reflect current thinking
• Drive and facilitate after action review meetings and results are documented
• Work with the team to assess and remediate impact to scope, budget, timelines
• Provide support for team-based reporting
• Mentor & support onboarding of new team members, particularly those in Trial Management.

Senior Clinical Project Manager

• Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery.
• Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration.
• Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track.
• Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives.
• Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders.

Senior Manager, Clinical Operations

• Contributes to the scientific planning and execution of one or more clinical trials.
• Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical studies.
• Develops leadership, technical skills, and scientific acumen as part of a global, cross-functional team.
• Responsible for specific clinical/scientific activities on a single study or across multiple studies (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials).
• Supports development of Protocol and related study materials (e.g., ICF documents/amendments, data management deliverables).
• May interact with internal and external stakeholders (e.g., country operations, committees, vendors) in support of clinical study objectives.
• Prepares clinical narratives
• Collaborates cross-functionally to monitor clinical study data to ensure quality, completeness, and integrity of trial conduct.
• Participates in CRF design to ensure data collection is in alignment with the protocol.

Scientist, Clinical Operations

• Contributes to the operational planning and execution of one or more clinical trials
• Develop leadership and technical skills as part of a global, cross-functional team
• Apply project management, communication, and collaboration skills in support of clinical trials
• May have specific operational responsibilities for a single study or across multiple studies
• May be responsible for tracking study timelines using project management tools
• Shares technical expertise with team members
• May interact with internal and external stakeholders in support of clinical trial objectives

Clinical Operations Scientist

• Responsible for the operational planning, feasibility, and execution of a clinical trial.
• May serve as the clinical trial team lead.
• May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities).
• Leads team for timeline management, risk identification and mitigation, issue resolution.
• May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives.
• Accountable for managing any study specific partners and/or vendors.

Senior Scientist, Clinical Operations

• Drive scientific planning, strategy, and execution of Phase 1-4 clinical studies
• Collaborate with global cross ­functional team members including clinical directors and study managers
• Responsible for the clinical/scientific execution of clinical protocol(s)
• Serves as the lead clinical scientist on the clinical trial team
• Collaborates with the Medical Writer on clinical/scientific and regulatory documents
• Partners with Study Manager on study deliverables
• Participates in the set up and design during study start up
• Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations

Associate Principal Scientist, Clinical Operations

• Provide line management to direct reports, including setting goals and objectives, performance evaluation and talent development.
• Evaluate and forecast resource needs for assigned portfolio and/or other specific areas of responsibility, as required and agreed with local DU management accordingly.
• Deployment of the One Delivery Model through collaboration and oversight of vendors.
• Accountable for the acquisition of new talents and development of human resources.
• Guide direct reports in issue resolution and communication with involved stakeholders.
• Lead organizational changes and effectively communicate on priority shifts as required.
• Review and approve expenses in compliance with the company policies.
• Demonstrate leadership behaviors in alignment with Johnson & Johnson Leadership Imperatives.
• Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
• Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
• Define, execute or support long-term strategy in alignment with DU, GD and Johnson & Johnson Innovative Medicine (JJIM) R&D strategies to position the local and global DU organization for success.
• Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other areas of responsibility, as required.
• Accountable for ensuring relevant operational objectives are met in conformance to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP), relevant SOPs and other procedural documents.
• Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.
• Contribute to Corrective and Preventative Action (CAPA) and issue resolution in accordance with required timelines.
• Shape and maintain strong relationships within local DU department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
• Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other areas of responsibility, as required.
• Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
• Review operational and quality metrics regularly and drive follow-up actions as appropriate.
• Drive innovative solutions and process improvements for the assigned therapeutic area(s), country, and DU/GD overall.
• Foster a culture of continuous improvement and innovation within the local DU team.

Associate Director, Clinical Operations – Study Start-up

• Build and Lead the OpEx Function
• Establish the OpEx vision, operating model, organizational structure and multi-year road map
• Build and mentor a high performing operational excellence team capable of driving enterprise transformation
• Partner with EPIX functional leads to embed operational discipline across the clinical lifecycle and GCO
• Standardize Operating Models
• Assess current operating models, map E2E processes to gain efficiency and speed.
• Design harmonized, scalable processes and frameworks for planning, forecasting, feasibility, budgeting, execution, enrollment management and closeout.
• Develop governance structures that drive consistency and eliminate operational variability across functions and geographies
• Lead "way of working" harmonization across Innovative and Generics portfolios
• Own Metrics and KPI Governance
• Define and maintain the metrics performance aligning KPI's to quality timelines, predictability, vendor performance, patient/site experience, and cost
• In collaboration with a partner organization, design dashboards and performance reviews that inform decisions at study/ functional/portfolio levels
• Collaborate with other functional areas to establish governance and steering committees
• Ensure metrics are actionable, driving accountability escalation and performance improvement
• Lead Enterprise Level Operational Initiatives
• Champion continuous improvement across planning, execution, governance, and vendor management
• Drive adoption of new processes systems tools and behaviors through structured change management and training
• Shape operational decision-making frameworks that support portfolio level prioritization and resource allocation
• Drive process simplification and implement technology enhancements to optimize speed, accuracy, and efficiency.
• Ensure Organizational Readiness and Scalability
• Define readiness criteria for key study milestones and ensure teams are equipped to meet them
• Build operating structures that support portfolio expansion new modalities and increasing trial complexity
• Align operational excellence strategies with technology, digital and AI/ML teams to maximize adoption and impact
• Oversee resource allocation and governance for GCO

Senior Director, Head Operational Excellence, Global Clinical Operations

• accountable for the execution of operational quality activities within the assigned therapeutic area
• oversee headquarters clinical quality operations and support clinical trial teams
• embed quality into the Company's sponsored trials
• ensure adequate vendor oversight and address quality issues
• develop quality plans to implement quality by design within clinical development programs
• maintain ongoing inspection readiness
• prepare for, manage and follow up on regulatory inspections

Clinical Quality Operations Manager, Oncology

• 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

• Provide country-level oversight of clinical trials from start-up through closeout
• Ensure high-quality data delivery and regulatory compliance
• Collaborate closely with cross-functional teams
• Manage site selection and patient recruitment strategies
• Support project execution and maintain inspection readiness
• Drive risk-based mitigation plans and resolve study challenges

Associate Clinical Project Manager, Sponsor Dedicated

• Provide leadership to the designated Area within CSSM
• Identify and drive enhancements/standardization of CSSM TA deliverables and tolls/processes to increase efficiencies
• Provide leadership during conduct of risk assessments and mitigation planning for priority program execution
• Ensure the successful execution for all headquarter based patient clinical trials

Executive Director, Clinical Operations, Oncology

• 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

• Accountable for TMF operations and processes
• Lead governance committee with TMF vendors
• Develop TMF-related standards and SOPs
• Provide expertise for inspection readiness
• Collaborate with senior leaders for reporting and analytics

Associate Director, TMF Operations, Clinical Operations Analytics

• Accountable for the company’s Trial Master File support model, processes, and systems
• Responsible for oversight and management of TMF vendors and associated processes for the TMF
• Primary point of contact related to TMF processes and systems and study specific TMF support, as appropriate.
• Develop and oversee global TMF-related standards, standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., CDISC Trial Master File Reference Model).
• Provide expertise and strong leadership to ensure inspection readiness and facilitate seamless support of audits and regulatory inspections.
• Review and provide expert TMF operations input into clinical documents, particularly study plans.
• Develop, generate, analyse, and present to leadership standard TMF metrics/KPIs to demonstrate TMF health.
• Lead the continuous evolution, implementation, and oversight of TMF support model.
• Provide operational leadership to TMF vendor budget negotiations and management of TMF operations spend.
• Lead and manage the relationship with TMF-related vendors, ensuring appropriate contract scope, budgets, vendor performance and issue resolution.
• Serve as TMF Operations functional area representative for the implementation of any systems or processes that would interface/integrate with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC).
• Lead governance committee with TMF Vendors
• Provides technical expertise and leadership to develop and execute Clinical Operations reporting and analytics strategies and initiatives that align with organizational business objectives.
• Create and generate sophisticated reporting, metrics/KPIs and other analytics that can be used to measure performance, compliance, and effectiveness.
• Lead interpretation of metrics and analytics to ensure accuracy, aligned stakeholder interpretation, and trends.
• Communicate performance metrics and KPIs to study teams, functional leadership, and senior management, identifying issues, trends, and opportunities.
• Ensure that portfolio of metrics, reporting and analytics solutions are fit for purpose at the company and are strategically aligned, accurate, scalable, and managed regarding functionality, utilization, and budget.
• Drive ongoing assessment of systems that support analytics and reporting to manage risks and gaps.
• Provides business oversight across all involved systems to ensure ongoing alignment and proper mapping of data in support of metrics/KPIs and Clinical Operations reporting.

• 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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