Associate Director, Clinical Safety Scientist

Location
Basking Ridge, New Jersey, United States
Posted
Oct 06, 2020
Ref
10511BR
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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 cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The Associate 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
  • 5 years of experience with an advanced degree; 7 years of experience with a bachelor's degree
  • 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.
Job Title
Associate Director, Clinical Safety Scientist

City
Basking Ridge

Functional Area
CSPV

State
New Jersey