What are the responsibilities and job description for the Director, Clinical Safety Scientist position at Daiichi Sankyo US?
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
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. This position may manage a team of scientists who support multiple products.
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. People Management and Mentoring: Coaches, mentors, and influences junior scientists and team members.
Qualifications
Education Qualifications
Experience Qualifications
Bachelor's Degree required or PhD preferred or PharmD preferred
7 or More Years of experience with an advanced degree required
10 or More Years of experience with a bachelor’s degree preferred
Experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology required
Possesses strong medical and drug development knowledge required
Strong Communication Skills Required
Experience in summarizing and presenting safety data required
Experience in project management and working in a matrix environment required
Travel Requirements
People management experience required
Ability to travel up to 5% of the time. Travel to other CSPV sites or medical conferences as needed
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.
Salary Range
USD$201,840.00 - USD$302,760.00
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. This position may manage a team of scientists who support multiple products.
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. People Management and Mentoring: Coaches, mentors, and influences junior scientists and team members.
Qualifications
Education Qualifications
Experience Qualifications
Bachelor's Degree required or PhD preferred or PharmD preferred
7 or More Years of experience with an advanced degree required
10 or More Years of experience with a bachelor’s degree preferred
Experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology required
Possesses strong medical and drug development knowledge required
Strong Communication Skills Required
Experience in summarizing and presenting safety data required
Experience in project management and working in a matrix environment required
Travel Requirements
People management experience required
Ability to travel up to 5% of the time. Travel to other CSPV sites or medical conferences as needed
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.
Salary Range
USD$201,840.00 - USD$302,760.00
Salary : $201,840