Manager, Clinical Safety

Location
Basking Ridge, New Jersey, United States
Posted
Oct 01, 2020
Ref
10504BR
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:

Position independently handles aspects of signal identification, evaluation, and risk mitigation across therapeutic areas. This position proactively creates communication plans for important safety topics and identified risks. Additionally, this position may serve as primary author for certain safety documents and regulatory submissions and reviews protocols and ICFs. 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 occasionally IPT members and other functions. Finally, this position works on the most complex problems and makes decisions regarding project management work within CSPV.

Responsibilities:

Risk Management (Signal identification, evaluation, mitigation): Is a key participant in developing, and possibly implementing, the risk management strategy for assigned products/ TAs. Demonstrates familiarity with PV/Epi related literature. Assists CS physician in assessing new signals. May independently integrate and analyze safety data from multiple sources to deliver comprehensive conclusions.

Safety Communication: Develops strategy for communicating safety information internally and externally with CS physician. May first author safety communications.

Documentation: Documents meeting discussions, decisions, action items, and SMT activities independently. Ensures the appropriate archiving of the team meeting documentation and SMT activities independently. Maintains a current signal tracking log independently.

Project Management: Serves as PM for SMTs devoted to larger Phase 3/4 products and ensures adherence to project timeline. Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately. 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.
  • Possesses strong medical or TA and drug development knowledge
  • 3 years of experience with an advanced degree; 5 years of experience with a Bachelor's degree
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
Manager, Clinical Safety

City
Basking Ridge

Functional Area
CSPV

State
New Jersey