Director, Clinical Safety

Location
Basking Ridge, NJ, United States
Posted
Nov 05, 2020
Ref
10536BR
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
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 Risk Management Director will coordinate and lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role will function as a key member of the Integrated Project Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).

Responsibilities:

Develop processes and procedures for identifying and evaluating risk management issues for compounds in development.

Effectively represent Risk Management department on the development Integrated Project Team providing risk management support and serving as the primary point of contact.

Review and analyze data from clinical trials for the prompt identification of safety signals. Review and Evaluate serious adverse event reports from clinical trials for completeness, accuracy, expectedness and relatedness.

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).

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
MD (or PhD in a relevant scientific discipline), Board certification or eligibility.

3-5 years' experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology. Senior Director 7- 10 years.

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.

Job Title
Director, Clinical Safety

City
Basking Ridge

Functional Area
CSPV

State
New Jersey