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WHAT
IN
Director CMC - Late Stage Small Molecule
Job
biogen idec
US
-
Cambridge ,
Massachusetts
Job Code - 10892BR
Position - See Job Description
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to biogen idec for this position!)
JOB DESCRIPTION: Director, CMC - Late Stage Small Molecule
A Late Stage CMC Team Leader is a strategic leader responsible for global CMC activities to support specific clinical development program/s from proof of concept to regulatory filing and commercialization
The CMC Team Leader represents all Pharmaceutical Operations and Technology (PO&T) line functions (Development, Manufacturing, Quality and Supply Chain) on the Program Team and develops a close relationship with the relevant Therapeutic Area. Responsibility scope may include management of external contract or collaborative development relationships and general support of CMC Management through continuous improvement initiatives
Principal Accountabilities:
1. Is the 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
2. 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
3. Establishes and leads a cross-functional CMC Team
a. Develops and leads a cross functional CMC team responsible for physical drug product development, manufacturing, supply of clinical material, regulatory filings and path to commercialization
b. Documents and appropriately communicates – scope to include product Development plans, integrated timelines and concise status reports
c. Leads and manages CMC-related interactions with third party program contractors or partners as necessary
4. Represents PO&T on the Program Team
a. 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
b. Communicates PO&T activities and positions to the Program Team
c. Authors PO&T components of IDP and Stage Gate Contract
d. Participates in R&D review and decision making forums as necessary
5. Works closely with relevant Therapeutic Area departments to understand TA-specific strategies for clinical development.
a. Leverages TA understanding to improve PO&T approaches and increase Program efficiency and/or effectiveness
b. Provides a guidance resource for early stage CMC teams within the TA
c. May represent PO&T at Therapeutic Area Committee meetings
6. Develops budget and forecast plans for development activities
a. Works with line functions to establish appropriate program support. Identifies and resolves conflicting objectives or resource barriers
7. Facilitates CMC Management matrix function through technical and operational initiatives to improve PO&T effectiveness and efficiency in support of development programs
REQUIREMENTS - QUALIFICATIONS: Director, CMC - Late Stage Small Molecule
A Ph.D. in Chemistry with 10 + years of experience in the pharmaceutical industry in areas related to CMC. Prior experience in leading CMC teams is essential. Experience with filing of an NDA and commercialization of a product would be a plus. Strong communication skills and the ability to work in a matrix environment are essential elements for this job.
a. Overall knowledge of drug development technical experience in at least one area of CMC
b. Previous experience on CMC teams and in leading cross functional teams
c. Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of the interdependencies of research, development, preclinical, clinical and regulatory functions
d. Demonstrated leadership and capability for strategic analysis and issue resolution. Organizational and project management skills working in a matrix environment
e. Excellent communication, negotiation, problem solving and decision making skills and a strong ability to influence or manage without direct authority
Ph.D. in Chemistry with 10 + years of experience in the pharmaceutical industry in areas related to CMC.
biogen idec
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