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| Biogen Idec, Inc. |
Cambridge |
MA |
11/20/2009
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| 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 |
| Biogen Idec, Inc. |
Waltham |
MA |
11/20/2009
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| Clinical Trial Manager |
â?¢Typically requires at least 5+ years of global drug development with experience managing clinical projects within time, budget, and quality expectations.
â?¢Experience in hematology/oncology clinical research and development very desirable, especially in the areas of hemophilia and clotting disorders.
â?¢NDA/BLA or MAA experience desirable, particularly within an orphan/rare disease therapeutic area.
â?¢Thorough knowledge of GCP, ICH guidelines and awareness of global regulatory requirements/differences for clinical development.
â?¢Detail and process oriented, with excellent project management skills, including risk assessment and contingency planning.
â?¢Demonstrated leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills.
â?¢Proven excellence in cross-functional matrix and/or cross-cultural partnership setting preferred. |
| Biogen Idec, Inc. |
Waltham |
MA |
11/20/2009
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| Clinical Program Leader |
â?¢Typically requires at least 8+ years of global drug development with experience managing clinical projects within time, budget, and quality expectations.
â?¢Experience in hemophelia, thrombosis and/or oncology clinical research and development is very desirable
â?¢NDA/BLA or MAA experience desirable, particularly within an orphan/rare disease therapeutic area.
â?¢Thorough knowledge of GCP, ICH guidelines and awareness of global regulatory requirements/differences for clinical development.
â?¢Detail and process oriented, with excellent project management skills, including risk assessment and contingency planning.
â?¢Demonstrated leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills.
â?¢Proven excellence in cross-functional matrix and/or cross-cultural partnership setting preferred. |
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