Director CMC Team Leader, Small Molecules

Principal Accountabilities:

• Serves as development program SME within PO&T and CMC Regulatory. Develops effective working relationships with key line functions to facilitate informed PO&T decision making for program related activities and issues. Depending on the program scope, may hold responsibility for one or more programs
• Develops, aligns, communicates and manages CMC strategy through clinical supply, validation, regulatory application and commercial launch to meet program goals and maintain PO&T objectives, including considerations for efficiency and cost. Maintains an understanding of developing commercial requirements for product and adapts strategy accordingly
• Establishes and leads a cross-functional CMC Team, responsible for physical drug product development, manufacturing, supply of clinical material, regulatory filings and path to commercialization, plus CMC-related interactions with third party program contractors or partners as necessary
• Represents PO&T on the program team: Develops, aligns and communicates program strategy, issues, goals and milestones through the CMC team to PO&T and Regulatory line functions. Interprets and disseminates Program Team information including Integrated Development plans (IDP) and Stage Gate Contracts
• Works closely with relevant Therapeutic Area departments to understand therapeutic area (TA)-specific strategies for clinical development and provide guidance for early-stage CMC teams
• Develops budget and forecast plans for development activities
• Facilitates CMC Management matrix function through technical and operational initiatives to improve PO&T effectiveness and efficiency in support of development programs

Qualifications

• 10 + years relevant experience in the pharmaceutical industry
• Prior experience in leading CMC and cross-functional teams is essential
• Overall knowledge of drug development and technical experience in at least one area of CMC
• Experience with filing of an NDA and commercialization of a product would be a plus.
• Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of the interdependencies of research, development, preclinical, clinical and regulatory functions
• Demonstrated leadership and capability for strategic analysis and issue resolution. Organizational and project management skills working in a matrix environment
• Excellent communication, negotiation, problem solving and decision making skills and a strong ability to influence or manage without direct authority

Education

• Ph.D. in Chemistry in areas related to CMC.

Biogen Idec is proud to be an Equal Opportunity Employer.

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