ELODIE CROS

• Define and implement global clinical supply strategy for all Allergan Aesthetic and Neurotoxins programs,

• Responsibilities include Drug Substance and Drug Product requirements, input into design control for medical devices, alignment on dosing strategy and management of external budgets.
• Lead the cross functional Clinical Supply Chain team for each asset, including matrix management of Clinical Supply Project Managers.

• Represent the clinical supply chain on Product Presentation and Device Strategy Teams (PPDSTs) and Integrated Evidence Strategy Teams (IESTs).
• Support integration efforts of Legacy Allergan manufacturing sites (Pringy, Branchburg, Westport).

• Provided functional leadership to the GCSM Planning Department and support the development and operational execution of the clinical supply strategy across Allergan’s R&D portfolio
• Managed a team of Project Leaders, includinghiring, direct supervision, coaching, performance management and personal development.
• Responsible for the department resource model forecast.
• Provided oversight and performance management of third party vendors
• Managed internal customer interface, line representative at R&D leadership meetings, provide technical, financial and risks assessment during quarterly portfolio reviews
• Lead the inspection readiness team and act as the line SME during regulatory inspections
• Provide technical and quality input during due diligence assessments

§ Clinical Supply Management Team Leader:

• Built, trained and led a team of Clinical Supply Project Managers responsible for the planning and delivery of clinical supplies to support global clinical studies for the growing Alexion's rare disease portfolio.
• Responsible for a $15M clinical supply operational budget
• Developed and managed strategic alliances with contract partners for packaging and distribution
• Defined and tracked key performance indicators and quality standards to improve performance and compliance
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• Lead the creation of the Clinical Research Pharmacy Unit, trained new hire, developed pharmacy manual template, set up process for direct to patients and remote infusions
• Acted as SME during internal audits and regulatory inspections

§ CMC Team Leader:

• Supported the creation of the CMC cross functional team model, conducted stakeholder analysis, developed team structure and created project management tools.
• Lead CMC project team for early phase monoclonal antibody compound.

• Led Clinical Supply Project Teams inclusive of Process Development, Manufacturing, CMC, QA, Packaging, Logistics and Regulatory
• Responsible for the development and execution of the clinical supply strategy (forecast, budget, timelines and risks) for early and late phase programs
• Serve as the primary liaison to Pharmaceutical Sciences Project Teams, Core Development Teams and Leadership Team
• Provided monthly portfolio updates to the Biotherapeutics Leadership Team
• Successfully supported the development of drug delivery strategies for sub cutaneous administration
• Negotiated clinical supplies and quality agreements for In and Out licensing deals

• Led process alignment initiative between UK and US clinical supply chain organizations
• Conducted the pilot for Clinical Supply Project Team model and supported the development of various project management tools

• Responsible for the timely and accurate delivery of clinical supplies to support late phase clinical programs
• Clinical Supply point of contact for Pfizer country offices: implemented forecasting tool and facilitated issues escalation & resolution process
• Led the clinical supply / CMC partnership meetings: reviewed process gaps and enhanced cross department communication

• Responsible for the delivery of clinical supplies for local clinical studies
• Managed packaging and distribution vendor activities, participated in vendor’s qualification audits and generated technical agreements
• Key driver in the set-up of the local clinical supplies department: conducted process gap analysis, created documentation (job descriptions, guidelines and local SOPs), developed and delivered training

• Responsible for the monitoring of clinical studies in accordance with GCPs and applicable regulations
• Change agent in the set-up of the Quality Assurance Department