Director, CMC Team Lead

This is what you will do:

The Director, CMC Team Lead is a strategic leader within the Product Development and Clinical Supply (PDCS) organization within Alexion R&D. This organizational leader will have primary responsibility for overseeing an asset throughout the drug development lifecycle from Candidate Selection through First Approval. This is a matrix leadership role that leads the CMC Team for an asset and collaborates cross-functionally to develop CMC Development plans while also providing tactical direction for the execution of the CMC Plan. This position will lead, coordinate, and monitor the CMC teams’ progress to ensure successful implementation and execution of the CMC strategy. The Director CMC Team Lead is the primary liaison for their program(s) to the enterprise Global Medicine/Product Teams (GMT/GPT). This is a key leadership position within CMC Program Management and PDCS and involves routine interaction with senior management.

You will be responsible for:

• Lead the development of the strategic CMC Development Plan for specific product(s) within PDCS.

• Set priorities, establish team goals, and plan activities to deliver the CMC strategy for the defined program(s)

• Ensure operational plans are in place and highlights key dependencies between execution teams and operational plans.

• Represent the CMC team as the sole point of contact to the Global Product or Global Medicine Teams as appropriate)and at Alexion internal governance bodies.

• Identify, and escalate key issues and risks according to the Alexion governance model.

• Drive decision making and the associated deliverables across all functions on the CMC Team 

• Build and maintain strong and diverse relationships across the organization, including key client groups, peers, senior management, et al.

You will need to have:

• Minimum of 8-10 years of experience in the biopharmaceutical industry, with prior experience in a CMC leadership role

• Demonstrated strategic thinking capabilities with forward looking perspective.

• Effective communication, leadership and collaboration skills are required.

• Solid understanding of drug development and clinic supply processes

• Demonstrated ability to build, organize and lead teams.

• Strong people skills; fluent and able to influence others in spoken and written English.

• The duties of this role are conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Prior experience as a liaison with corporate partners preferred.

• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, Project, and PowerPoint. Knowledge of MS Project Server a plus