Sr. CMC, Global Project Manager

Title: Sr. CMC, Global Project Manager

Company: Ipsen Pharma (SAS)

About Ipsen

Ipsen is a mid‑size global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. With global hubs in the U.S., France, and the U.K., we tackle unmet medical needs through research and innovation.

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 Senior CMC Global Project Manager (GPM) works with the CMC Lead, Asset Operations Lead (AOL), and the Asset Team (AT) to develop, implement and manage a strategic CMC roadmap, driving the cross‑functional CMC Subteam. The Senior CMC GPM serves as the central point of contact for the CMC Subteam and may act as deputy for the CMC Lead. The role also supports transversal projects within GPO to improve operational efficiencies across Asset Operations, CMC, and GPO teams.

Main Responsibilities

Project Operational Leadership

• Serve as the central operational point of contact for CMC, project subteams, and Asset Team members.
• Partner with the CMC Lead and functional reps to create and maintain the asset CMC roadmap.
• Foster a climate of personal investment, excellence, and commitment to common goals.
• Facilitate evaluation of alternative development options and win/win solutions for program/team conflicts.
• Promote ideas persuasively and build on others’ ideas.

Project Management

• Create and maintain a CMC Project Plan across functional lines, updated at least once a month.
• Integrate function planning to support the CMC project plans; create scenario planning and risk analysis.
• Align subteam deliverables with Global Asset Plan and manage quality, risk, cost, and time.
• Validate technical integrity of project plans and drive decisions at the CMC subteam meeting.
• Update full‑scale CMC project plans, timelines, budgets, and milestones in the appropriate tool.
• Implement cross‑functional monthly CMC operational meetings to monitor execution.

Risk Management

• Apply a consistent risk management methodology to identify CMC risks and opportunities.
• Develop and deliver appropriate contingencies or corrective actions.
• Communicate risk status to governance bodies and support project strategy.

Budget and Resource Management

• Partner with the CMC Lead, Finance, and AOL to establish budget and resource plans.
• Manage CMC project budget and resource plan; record actuals and align with forecasts.
• Support vendor selection and management as required.

Knowledge Management

• Conduct lessons‑learned workshops and apply learnings across the portfolio.
• Benchmark against competitors and challenge plans and decisions.

Communication & Reporting

• Effectively communicate project expectations to subteam members, senior leaders, and the broader organization.
• Escalate issues timely; streamline governance process and decision making.
• Define and implement a communication strategy; report metrics to measure performance.

Competency Matrix

• Stakeholder Management: manages senior stakeholders and ensures alignment.
• Regulatory & Compliance Knowledge: intermediate knowledge of regulatory frameworks.
• Drug Development Expertise: intermediate knowledge across all phases.
• Risk & Issue Management: assesses risks, develops contingency plans.
• Budget & Cost Control: leads cross‑functional discussions on cost efficiency.
• Communication & Negotiation: engages senior stakeholders and resolves conflicts.
• Cross‑Functional Team Leadership: supports cross‑functional CMC teams.
• Technology & Data Management: advanced use of corporate project management tools.
• Change Management & Process Improvement: implements process improvements to increase efficiency.
• Leadership & Mentorship: mentors junior CMC project managers.
• KPI & Performance Tracking: ensures activities meet KPIs.
• Strategic Thinking & Innovation: prioritizes activities and integrates process improvements.
• Planning: develops integrated CMC project plan and execution roadmaps.
• Data, Data Management & Analytics: analyzes project data for decisions.

Knowledge & Experience

• 8‑10+ years in the Pharmaceutical/Biotech industry with experience in CMC development of manufacturing, formulations, and across modalities.
• Deep understanding of drug development process, clinical development, early and late phase, filing and launch phases.
• Experience leading operations in cross‑functional drug development teams.
• Agile, proactive, emotional intelligence to lead with influence.
• Ability to multitask, prioritize, solve problems, manage conflict, and keep the big picture.
• Excellent communication, interpersonal, networking, stakeholder management skills.
• Financial acumen to develop and manage project budgets.
• Proficient in Microsoft Office, Microsoft Project, and other PM tools.
• Patient focus and strong customer orientation.

Preferred Knowledge & Experience

• US / EU pharmaceutical regulations experience.
• Experience within one or two functional areas (CMC, clinical, preclinical, regulatory).

Education / Certifications

• Bachelor’s Degree in Science (essential).
• Certification in Project Management (preferred).
• PhD or PharmD is a plus.

Languages

• English (essential); French (essential).
• English (preferred); French (preferred).

EEO Statement

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons «The Real Us». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l’inclusion et de l’égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d’aménagements ou d’aide pendant le processus de candidature, veuillez en informer l’équipe de recrutement. Ces informations seront traitées avec soin et n’auront aucune incidence sur le résultat de votre candidature.