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Daiichi Sankyo, Inc.

Director Clinical Safety Scientist

Post Date:Dec 29, 2019Type:Full-Time
Start Date:12/29/2019Salary:
Location:US-NJ-Basking Ridge Job Reference:10039BR
Skills:
 

Job Description:
Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

The Director, Clinical Safety Scientist, will handles aspects of signal identification, evaluation, and risk mitigation across therapeutic areas, in collaboration with product safety leads. This position proactively creates communication plans for important safety topics and identified risks. This position may serve as primary author for certain safety documents and regulatory submissions. Additionally, this position project manages larger Phase 3 or 4 SMTs and supervises junior scientist project managing smaller SMTs. This position works closely with CSPV staff, SMT members and other functions.

Responsibilities:
  • Risk Management (Signal identification, evaluation, mitigation): Is a key participant in developing and implementing the risk management strategy for assigned products/ TAs; Independently integrates and analyzes safety data from multiple sources to deliver comprehensive conclusions; Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately.
  • Safety Communication: Develops strategy for communicating safety information internally and externally in collaboration with product safety lead. Leads the development of safety communication documents and aggregate safety reports.
  • Project Management: Serves as PM for SMTs devoted to larger Phase 3/4 products and ensures adherence to project timeline.
  • Mentoring: Coaches, mentors, and influences junior scientists and team members.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Bachelor’s degree at minimum required; PharmD or PhD preferred
  • 7 years of experience with an advanced degree; 10 years of experience with a bachelor’s degree
  • Experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.
  • Possesses strong medical and drug development knowledge
  • Experience in summarizing and presenting safety data
  • Strong communication skills
  • Experience in project management and working in a matrix environment
  • People management experience is desired but not required
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.




Contact Information
Daiichi Sankyo, Inc.



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