FierceBiotech and FiercePharma Jobs
Sr. Program Advisor - Charles River
Categories: Project Manager
Website: http://www.criver.com
Position Description
We are seeking a Senior Program Advisor to join Charles River Navigator Services. This position is located in our Shrewsbury, Massachusetts facility.
Essential Duties and Responsibilities
• Reports to Director of Program Management, Charles River Navigator Services.
• Provides preclinical program management and consulting for programs placed within Charles River Laboratories, Preclinical Services
• Works closely with operational departments; is responsible for coordinating multi-disciplinary activities related to the preclinical development of programs
• Provides in-house senior scientific and regulatory review and oversight of study protocols and reports as requested
• Assists clients in the planning, execution and interpretation of preclinical (toxicology and DMPK) studies required for regulatory approval
• Consults with clients on regulatory strategy as part of the client’s drug development planning
The position does not require study direction or execution.
Qualifications:
• An advanced degree in toxicology or related field
• At least 10 years of preclinical drug development experience pharmaceutical or biotech setting
• Board certification (DABT) is preferred.
Specific skills:
• Comprehensive knowledge of Good Laboratory Practices (GLPs)
• Strong knowledge of preclinical regulatory requirements and guidances (FDA, EMEA, ICH).
• Ability to handle multiple projects, prioritize work and meet deadlines.
• Proficiency in standard software including Microsoft® Project, Excel, Word, Powerpoint, etc. and with standard laboratory calculations and statistical procedures.
Excellent communication and interpersonal skills are required. This position involves interaction with clients as well as internal staff at all levels and in all departments. The candidate must be a team player with a proven track record of conflict resolution and communication.
Contact:
Irene Bergman
Charles River Laboratories
Telephone: 508-925-6218
Email: Irene.bergman@crl.com
How to Apply
Contact: Parthena Martin, PhD, DABT Charles River Laboratories Telephone: 775-682-2037 Email: Parthena.Martin@crl.comApplication Instructions / Send a Resume
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