Clinical Supply Chain CDMO Project Manager

Clinical Supply Chain CDMO Project Manager

Company:
Ipsen Biopharmaceuticals Inc.

Responsible for managing outsourced clinical packaging and distribution operations in compliance with Good Manufacturing Practices. Supports the Clinical Supply Chain CDMO Management Lead to establish and maintain collaborations with external vendors to ensure supply of materials required for clinical studies. Executes responsibilities in line with internal and external regulatory guidance, meeting timelines, resources, and budget. Contributes to continuous improvement and knowledge management related to development of new chemical entities and product lifecycle management.

• Define planning for packaging, labeling and distribution per clinical forecasts and timelines in collaboration with CDMOs and Clinical Supply Chain Therapeutic Area groups.
• Ensure on‑time supply of IMPs to patients with no stock‑outs.
• Support CDMO selection and maintenance.
• Assess impact of changes in clinical studies on planning and propose mitigation plans.
• Coordinate and lead meetings with CDMOs responsible for clinical packaging and distribution.
• Monitor CDMO performance through KPIs.
• In collaboration with Suppliers Quality Assurance, set up and maintain Quality Technical Agreements.
• Ensure timely availability of documents required for activities (instructions, batch records, reports, specifications).
• In collaboration with Operational Quality Assurance, review batch records and instructions of clinical IMPs.
• Manage quality events (deviations, change controls) in line with KPIs.
• Ensure activities are performed within agreed budget and procurement processes (request quotes, launch commitment requests, place purchase orders).
• Ensure timely vendor payments and diligent invoice review.
• Develop and maintain a network of efficient CDMOs/vendors.
• Implement and maintain collaboration to procure comedications and/or comparators.
• Maintain collaboration to supply materials for internal packaging and distribution (booklet labels, packaging materials).
• Monitor clinical kit destruction process under CDMO responsibility when required.
• Present project results and progress at internal technical meetings.
• Ensure regulatory surveillance for activities (GMP, Annex 13, Annex 1, guidelines).
• Develop and optimize team interfaces within GCSM and with Operational Quality Assurance and Drug Product Management teams.
• Support Process and Compliance Project Manager to define/adjust GCSM processes and provide continuous feedback.
• Organize and participate in lessons‑learned exercises.
• Contribute to continuous improvement projects within Global Clinical Supply Management and broader Pharmaceutical Development.

• Respect Good Practices applicable (BPF, BPD, etc.), and follow Energy, Environment, Health and Safety procedures as per company policies.

• Apply and proactively contribute to actions for CSR development according to Ipsen guidelines.

• Excellence in execution – prioritize, plan, set clear KPIs, focus, deliver impact, promote accountability.
• Ensure Accountability – single accountable referents per task, communicate clearly, seek stakeholder input, take personal accountability, follow through commitments.
• Collaborates – communicate across boundaries, remove barriers, focus on continuous improvement, resourceful, entrepreneurial mindset.
• Influences – listen, observe, build common interests, seek win‑win partnerships, influence without direct authority.
• Manage Complexity – identify contradictory information, evaluate alternatives, prioritize real impact decisions.

• Minimum 5years’ experience in a comparable pharmaceutical role, with international exposure.
• Bachelor’s degree or equivalent in pharmacy, engineering, operations, or supply‑chain management.
• Experience managing complex investigational supplies for global clinical trials through external networks.
• Experience in project management and facilitating communications in a highly matrixed environment.
• Preferred experience with Clinical Packaging, Distribution and Sourcing CDMOs.
• Preferred experience…