Sr. CMC, Global Project Manager

Titre : Sr. CMC, Global Project Manager Société: Ipsen Pharma (SAS) A propos d'Ipsen: Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.

Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d’Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s’épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.

Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram . Description de l'emploi : WHAT - Summary & Purpose of the Position All Ipsen’s assets are managed through a fully integrated Asset Team focused on maximizing patient value and the success of the asset in all aspects across its entire lifecycle. The main mission of the Senior CMC Global Project Manager (GPM) is to work in collaboration with the CMC Lead, the Asset Operations

Lead (AOL), and the Asset Team (AT) to develop, implement and manage strategic CMC roadmap by driving the cross functional CMC Subteam. The Senior CMC GPM closely partners with the CMC Lead to serve as the central point of contact for the CMC Subteam members and when necessary, serves as deputy for CMC Lead. A CMC GPM may support multiple assets. The secondary mission of the Senior CMC GPM is to support transversal projects/initiatives within GPO, with the aim of improving operational efficiencies across Asset Operations, CMC and GPO teams’ scope of responsibilities.

The Senior CMC Global Project Manager is responsible for the creation, maintenance and execution of the operational CMC plans to enable the successful CMC delivery of the project. They ensure that all steps of the CMC project plan are anticipated, planned, coordinated and followed up to deliver in the most efficient process. They are responsible for providing guidance, instruction, and leadership skills to develop optimal CMC roadmap on each asset and to inspire the team to perform at their optimum.

They monitor and track its associated budgets (internal and external costs) and support resource management against agreed strategic objectives for the program. There are responsible for ensuring consistent communication between project CMC functions and for ensuring key issues are escalated to management in due time and with a mitigation plan.

The Senior CMC GPM also ensures that a consistent project risk management methodology is applied at the Asset Team and CMC Subteam level to proactively identify project risks and opportunities together with contingencies and to use learning and experience from current, previous projects, competitor benchmarking and from the network of Global Project Managers to support successful delivery (knowledge management).

A CMC Subteam is defined as a cross functional team accountable for concrete deliverables such as IMP and IND/NDA or could be all activities related to the development of the asset in one indication / population (clinical development, CMC, regulatory, industrial and commercial). WHAT -

& Technical Competencies Project Operational Leadership

• Serve as the central operational point of contact for CMC, project subteams and Asset Team members
• Work in partnership with the CMC Lead, Functions reps to create and maintain asset CMC roadmap from overall asset strategy execution
• Create a climate that fosters personal investment and excellence and nurtures commitment to common goals
• Facilitate the process for evaluation of alternative development options at the CMC and project levels to deliver programs
• Facilitate win/win solutions for program/team conflicts with big picture in mind. Promote ideas persuasively and build on the ideas of others Project Management
• Create and maintain CMC Project Plan across functional lines, capturing interdependencies between all functions and deliverables, to be updated at least once a month, highlighting critical path and upcoming deliverables, and aligned with the Global Asset Plan
• Partner with CMC Lead and functional reps to ‘pressure-test’ assumptions and integrate function planning to support the CMC project plans
• Create and maintain the asset CMC Assumptions slide as a key input to the project plan, scenario planning, risk analysis and budget
• Define the interdependent CMC subteam deliverables aligned with Global Asset Plan and ensure that quality, risk, cost, time are managed to drive delivery of asset roadmap milestones and objectives on time and on budget
• Validate the technical integrity of the CMC project plans ensuring that the technical data is reviewed and discussed at the CMC subteam meeting for appropriate decision making/recommendation to the Asset Team on follow-up actions
• Update full-scale CMC project plans, timelines, budgets and milestones regularly in the appropriate tool to ensure data for metrics reporting is accurate
• Drives with the CMC Lead milestone decision point planning, execution of CMC plan and associated deliverables across functions to achieve the overall asset objectives.
• Implement and drive cross-functional monthly CMC operational meeting to closely and proactively monitor the execution of plans, measures result, update and align key planning assumptions with corresponding timing, risks, resources, and budget impacts and communicate deviations/discrepancies to AOL, specifically focusing on:
• Deliverables on time / at risk
• Key milestones
• Budget / Resource
• Contingencies
• Resource constraints if required.
• Issues and correct deviation to ensure successful project delivery
• Clearly define the critical path and generate clear decision criteria for the project
• Ensure decisions and actions are tracked in due time
• Perform oversight of all activities and associated deliverables under the accountability of the CMC subteams
• Demonstrate an appropriate level of technical understanding of the various functions to ensure effective cross-functional communication
• Responsible for ensuring that all the projects CMC functions deliver with precise execution, quality, on time and within budgets
• Proactively manage changes in project scope, anticipating potential problems (potential resource bottlenecks, risks to critical milestones, inefficient processes, and resource variance) and proactively develops and seeks approval for risk mitigation plans
• Responsible for supporting functional leads in vendor selection and management as required
• Comply with all laws, regulations and policies that govern the conduct of IPSEN activities. Always follow IPSEN policies, procedures and processes (including Global R&D Operation ones, such as governance process)
• Actively adhere to a Quality Management System (QMS) that supports GxPs and Regulatory requirements and satisfy all internal quality and external regulatory authority expectations
• Ensure project / workstream deliverables are managed to enable completion on time and according to required scope and budget, while applying the best practices and tools of an efficient PMO Risk Management
• Apply a consistent and comprehensive risk management methodology that proactively identifies CMC risks and opportunities together with developing and delivering appropriate contingencies and/or corrective actions to support the team in development of solutions to project conflicts and issues
• Apply a deep understanding of risk management methodology in using risk to communicate effectively with Governance bodies and underpin project strategy and delivery. Budget and Resource Management
• Partner with the CMC Lead and function representatives in the CMC subteam to ensure that budget, resource management and project controls are established.
• Manage CMC project budget and resource plan in partnership with the AOL, CMC Lead, Finance lead, function heads and function representatives in the team
• Support AOL to lead budget sessions at intervals that align with Finance budget/forecast calendar delivering and to translate board decisions to team and project budgets
• Ensure actuals are properly recorded and coded to the project
• Ensure all supportive materials and data are provided for tax credit requests on due time
• Support CMC Lead to ensure resource, cost and schedule are up to date to enable long term planning Knowledge Management
• Perform “lessons learned” workshops to identify CMC project learnings to be applied across the portfolio on an as-needed basis (at minimum at stage / gate)
• Develop a mindset around benchmarking versus competitors and use this approach to challenge plans and decisions with the team Communication and Reporting
• Effectively communicate project expectations to CMC subteam members, senior leaders and the broader organization. Escalate issues to team members and stakeholders in a timely fashion.
• Define governance strategy, streamline governance process and decision making at the Asset level, create and communicate governance material with all involved stakeholders and the PFM team.
• Prepare and manage governance interactions in partnership with the CMC Lead and AOL
• Define and implement a communication strategy / plan for the project that supports the most effective team empowerment and progress.
• Define and report metrics to measure project performance, while executing the plan Senior CMC Global Project Manager (GPM) Competency Matrix: Competency Senior CMC Global Project Manager Stakeholder Management Manages senior stakeholders, including senior cross-functional teams. Acts as a primary point of escalation and ensures alignment across functions. Regulatory & Compliance Knowledge Intermediate knowledge of regulatory frameworks, submission processes, and compliance risks. Drug Development Expertise (by Stage) Intermediate knowledge across all phases. Depends on functional leads for deep scientific execution. Ability to ensure overall CMC plan alignment with development plans and anticipate activities interdependencies Risk & Issue Management Proactively assesses risks across multiple activities. Develops contingency plans and mitigates potential delays or budget overruns. Escalates major issues to AT and senior management Budget & Cost Control Understand the key drivers of budget changes, can lead cross-functional discussions to develop, manage external costs and resource forecast.

Work with finance to ensure cost efficiency. Communication & Negotiation Engage with senior stakeholders. Ensures effective cross-functional communication to resolve conflicts and drive project success. Cross-Functional Team Leadership Supports cross functional CMC teams, ensuring alignment across multiple function representatives (regulatory, manufacturing, formulation, analytics, quality and supply). Drives collaboration across functions reps in the CMC Subteam.

Technology & Data Management Advanced use of corporate project management tools to build and maintain plan, track progress, milestones, and risks. Prepares dashboards to assess project performance and support strategic decisions. Change Management & Process Improvement Implements process improvements to increase efficiency. Drives continuous improvement within project teams. Leadership & Mentorship Mentors junior CMC project managers. Provides guidance on