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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. |
| Biogen Idec, Inc. |
Seattle |
WA |
11/20/2009
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| Senior Program Officer - Agricultural Development |
• Minimum of ten years experience in the development and management of projects involving crop improvement, crop management, extension research and/or seed systems for Africa or South Asia
• A PhD or other advanced degree in a discipline relevant to crop improvement, including plant breeding, molecular marker applications, agronomy or a closely related field
• The capacity to think through, evaluate, justify, and make major investments in agricultural research and development
• An outstanding record of achievement and leadership in the field
• Experience developing, managing, and implementing project strategies and the negotiation, execution, conduct and management of performance-based contracts
• Experience with grants or cooperative agreements
• Ability to think/work at scale as well as “work in white space,” create new ideas, strategize with passionate commitment to a successful outcome
• Demonstrated excellent written and oral communication skills in positions requiring communication with a broad and diverse audience
• Ability to prioritize, focus, and achieve results in a fast paced environment
• Track record of working well with others in teams; sense of humor
• Selfless dedication to the mission, flexibility, and willingness to learn
• Overseas experience and the ability to travel internationally |
| Biogen Idec, Inc. |
Waltham |
MA |
11/20/2009
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| Scientist II |
â?¢3-5 years of industry experience in (peptide/protein) analytical chemistry in a research/product development setting.
â?¢Understanding and hands-on experience with a wide range of analytical chemistry techniques: HPLC (reversed-phase, size-exclusion, ion exchange), Electrophoresis (SDS-PAGE/IEF/CE), Protein Sequencing, Peptide Mapping, Carbohydrate Analysis and Mass Spectrometry.
â?¢Knowledge and experience with amino acid post-translational modifications.
â?¢Understanding and hands-on experience with biophysical techniques: ITC and Light Scattering
â?¢Excellent oral, written and interpersonal communication skills and an ability to work across scientific disciplines.
â?¢Experience with FDA/ICH guidelines.
â?¢Knowledge of statistics and the ability to interpret experimental data to summarize the key findings.
â?¢Meticulous attention to detail in following procedures, preparing written documentation and execution of experiments.
â?¢Perform complex assays and investigate/troubleshoot assay problems. |
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