Senior Director, Clinical Safety

Basking Ridge, New Jersey
Jul 23, 2021
Pharm Country
Required Education
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:

The Senior Director, Clinical Safety will coordinate and lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Sankyo’s development compounds. This individual will use strong leadership and communication to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role will partner with Integrated Development Team members in Clinical, Regulatory, Project Management, Biostatistics, and Pharmacology, and other key stakeholders in strategically managing benefit-risk throughout the lifecycle of the drug.

  • Develop processes and procedures for identifying and evaluating risk management issues for compounds in development.
  • Review and analyze data from clinical trials for the prompt identification of safety
  • Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk management assessment of assigned projects/products.
  • Define and implement strategies and action plans for managing risk management issues throughout the product life cycle.
  • Effectively coordinate and manage available resources in developing and delivering high-quality risk management documents/deliverables (e.g., Risk Management Plans) to agreed timelines.
  • Coordinate and participate actively and influentially in regulatory risk management activities (e.g., regulatory meetings, post-approval commitments).
  • Effectively represent Risk Management on the project Integrated Development Team providing risk management support and serving as the primary point of contact.
  • Ensure compliance with regulatory standards and guidelines and corporate SOPs as they relate to risk management.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

  • MD or PhD in a relevant scientific discipline
  • 7-10 years experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.
  • Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.
  • Ability to review and analyze data and communicate complex information and analyses to a variety of scientific and non-scientific audiences.
  • Proven ability to think creatively and to develop strategic plans that demonstrate sound judgment.
  • Experience working cross-culturally in a global pharmaceutical environment.
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.