Join a Legacy of Innovation 110 Years and Counting!
With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a \"Global Pharma Innovator with a Competitive Advantage in Oncology,\" Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
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.
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.
Education and Experience
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
Clinical Safety experience required
Bachelor's degree at minimum required; PharmD or PhD preferred
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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 Scientist
City Basking Ridge
Functional Area CSPV
State New Jersey Associated topics: bio, bioengineering, biological engineer, biomechanics, biomedical, genetic, hereditary, msat, nutrition, therapeutic
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.