Sr. Director, Clinical Safety – NJ

This position spearheads the development and implementation of global and integrated project/product risk management strategies, including developing processes/procedures to identify and evaluate safety signals for products

Job Summary

Position independently and effectively leads SMTs at any stage of development and is recognized as the product safety expert for assigned products at any stage of development. This position spearheads the development and implementation of global and integrated project/product risk management strategies, including developing processes/procedures to identify and evaluate safety signals for products. This position soundly and thoroughly integrates safety data from all sources to perform safety assessments, and to determine the safety profile of assigned products. In doing so, this position interacts with internal and external stakeholders to globally vet and communicate safety issues and serves on the TR-PT/IPT. Finally, this position reviews and approves safety documents and works on complex safety problems with minimal managerial review, such as the approach to safety assessment and regulatory response for a novel and serious safety signal. 

Responsibilities

Safety Expert – Overall: Serves as the physician responsible for determining the safety profile and for leading SMTs for assigned products from development through LCM. Defines the risk component of the B/R assessment. Is the primary author for the RMP. Maintains expert knowledge of regulations and guidance related to safety reporting and safety surveillance.

Safety Expert – Signal Identification: Creates signal identification methods for global products with minimal managerial input. Mentors, trains, and supervises junior staff involved in signal identification efforts.

Safety Expert – Signal Evaluation: Creates the approach to signal evaluation for global products with minimal managerial input. Supervises junior staff during signal evaluation efforts. Integrates and evaluates data to deliver comprehensive conclusions.

Safety Expert – Risk Mitigation & Communication: Is critically involved in creating, proposing and implementing risk mitigation actions for global products. Gains internal and external buy-in. Globally communicates product safety information to all internal stakeholders and works closely with Public Affairs to formulate communication for external stakeholders.

Reports and Submissions: Provides comprehensive and integrated reviews of safety sections in documents containing safety information. First authors white papers involving safety. Provides medical review for US and EU periodic reports. Is the primary owner of the RMP.

Qualifications

Education and Experience

  • Requires MD degree or equivalent
  • 5 years of relevant experience and board eligibility

to apply: please email resume and cover letter to jobs@tseworldwide.com

Author: TSEWORLDWIDE

Michael is a 1996 graduate from Rutgers, The State University of NJ where he majored in Political Science. After Rutgers, Michael spent a year in Israel studying and working with early stage tech companies. After returning to the US, Michael spent 5 years with The Princeton Review in Operations of their graduate level courses. In 2001, Michael joined a staffing company where he led his office in sales of IT consulting services. In 2003, Michael started TSE and quickly found a niche in Strategy Consulting. He has formed partnerships with some of the leading consultancies in the areas of portfolio strategy, commercial assessment, market assess, payer strategy and operational effectiveness. Michael has helped consultancies and client side companies make key hires. In addition to recruiting, Michael helped Rutgers University create their Center for Innovative Ventures of Emerging Technologies and served as an Entrepreneur-in-Residence and Sounding Board Member for 5 years. He continues to stay active in the field of higher learning helping students of the sciences think about careers in the pharmaceutical industry.