Director, Clinical Safety Scientist (Basking Ridge)

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 SummaryThe 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.ResponsibilitiesRisk 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.QualificationsEducation QualificationsBachelor's Degree required; PhD preferred or PharmD preferredExperience Qualifications7 or More Years of experience with an advanced degree required10 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 Experience in summarizing and presenting safety data required Strong communication skills required Experience in project management and working in a matrix environment required People management experience required Travel RequirementsAbility to travel up to 5% of the time. Travel to other CSPV sites or medical conferences as neededDaiichi 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$302,760.00Download Our Benefits Summary PDF