Dir Clinical Safety in Basking Ridge, NJ at DSI

Date Posted: 11/26/2021

Job Snapshot

Job Description

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 leads SMTs and is a recognized product safety expert for assigned Phase 1 and 2a products. Oversee ongoing safety of Phase 3 studies as lead CS physician and serve as the CSPV functional rep at Global multifunctional project team meetings. This position prepares, summarizes, and reviews aggregate safety analyses.  Additionally, this position develops and implements integrated project/product risk management strategies and drafts the Risk Management Plan with Level III.  This position performs safety assessments and determines the safety profiles of assigned products.  This position also works with other CSPV staff and SMT members and serves as the CSPV representative on TR-PT/IPT on Phase 1 and 2a products.  This position may review and approve safety documents. Finally, this position also handles moderately complex safety matters, such as CSPV’s preliminary proposal for safety monitoring in Phase 2 study with well-known AESI, with manager support. 
 
Responsibilities
 
1. Safety Expert – Overall: Serves as the physician responsible for safety profile and for leading SMTs for assigned Phase 1 and 2a products. Defines the risk component of the B/R assessment. Has good working knowledge of regulations and guidance related to safety reporting and safety surveillance.
Regarding “late stage”, the new hire will help support the clinical development plan including Ph 3 studies including MDACC, Investigator initiated studies, Compassionate Use program (EAP study),  Q-Peds study (which is considered Ph1/2). Some early Combination studies including PLexxikon could be considered Ph 1/2 as well.
2. Safety Expert – Signal Identification: Performs more advanced aggregate signal identification activities formulated by manager.
3. Safety Expert – Signal Evaluation: Assists manager in assessing signals by surfacing and assembling relevant data and conducting analyses of datasets.
4. Safety Expert – Risk Mitigation & Communication: Supports manager in recommending and implementing risk mitigation activities. Proposes risk mitigation solutions to management and SMT.
5. Reports and Submissions: Contributes to and reviews safety sections of the NDA, CSR, and IB. May first author white papers involving safety. Provides medical review for US and EU periodic reports. Co-owns RMP with manager.
 
Qualifications
 
Education and Experience

  • MD degree
  • 3 years of relevant experience and board eligibility

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.