Associate Director, Clinical Safety Scientist
- Employer
- Daiichi Sankyo
- Location
- Basking Ridge, New Jersey, United States
- Start date
- Oct 6, 2020
View more
- Discipline
- Clinical, Clinical Research, Manufacturing & Production
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country
Job Details
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.
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
Job Title
Associate Director, Clinical Safety Scientist
City
Basking Ridge
Functional Area
CSPV
State
New Jersey
Company
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.
For more information, please visit: www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.
STOCK EXCHANGE: Tokyo Stock Exchange
STOCK SYMBOL: 4568
- Website
- http://www.daiichisankyo.com/
- Phone
- (908) 992-6400
- Location
-
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States
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