SR. DIRECTOR, LEAD GLOBAL PRODUCT SAFETY

Other
Judge Group
United States
Mar 2012
This job posting expired on May 13, 2012.
Location: NJ
Salary: Open
Description: * Minimum of completed MD (or international equivalent) plus accredited clinical residency experience required * At least 10 years experience as an MD in clinical research required * At least 5 years pharmaceutical industry experience required * At least 3 years drug safety experience required * Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred. * Experience/background in Immunology-Inflammation desirable. This position will be working with the Immunology-Inflammation (I&I) franchise. * To create and maintain a single interpretation of global safety data for defined products in development * To identify and manage safety concerns with development products * To assist the Medical Affairs study teams in pursuit of team goals * To provide a robust assessment of developmental product safety upon which marketed product safety surveillance may be based Responsible for: * Identifying and managing safety concerns for pre-approval products * Assisting Medical Affairs trials teams in the identification and handling of product safety concerns * Creating co-ordination at the product level across the Global Drug Safety Dept * Maintaining knowledge of safety profiles for treatments in a specific therapeutic area, including both company and competitor products Key Activities: Governance * Product Development Committee * Product Development Team Participation * Study Review Committee Representation * Company Safety Committee (CSC) * Internal DMCs * External DMCs Product Labeling * Labelling Working Group participation * Core Data Sheet Creation * Core Data Sheet Maintenance * Package Insert Key Requirements/Knowledge: * Minimum of completed MD (or international equivalent) plus accredited clinical residency experience required * At least 10 years experience as an MD in clinical research required * At least 5 years pharmaceutical industry experience required * At least 3 years drug safety experience required * Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred * Mastery of global regulatory requirements for pharmacovigilance * Clinical knowledge of therapeutic area patient populations and drug class * Knowledge of clinical research techniques and analysis methods * Issue and crisis management Leadership Competencies * Drive Innovation * Shape Strategy * Attract and Develop Talent * Promote Open Communication * Create Global Mindset * Demonstrate Adaptability * Foster Risk Taking * Foster Teamwork Competencies /Skills * Ability to use scientific and clinical knowledge to conceptualize study designs * Ability to anticipate and resolve problems * Ability to lead cross functional efforts and teams * Proficiency in data interpretation * Excellent skills in oral and written communication * Excellent interpersonal skills and ability to communicate effectively with people in different functions * Good listening skills and a strong willingness/desire to help resolve issues faced by others around them * Strong presentation skills * Sound organizational skills Internal/external partners: * Clinical Development * Medical Affairs * Clinical Investigators/KOLs * Global Regulatory Internal/External * Trial Safety Managers & other Global Safety MD
Contact: dfarrell@judge.com
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