Senior Director, Clinical Safety MD

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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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.

SUMMARY

The Sr. Director, Clinical Safety MD, will 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 through the Safety Management Team framework. 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 may function as a key member of the Global Product 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

• Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
• Effectively represent the CSPV on the Global Product Team or other cross-functional teams providing the safety leadership and serving as the primary point of contact.
• Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals.
• Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.
• Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.
• Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time.
• Coordinate and participate actively in safety-related regulatory interactions (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 Qualifications (from an accredited college or university)

• MD Board certification or eligibility required

Basic Requirements

• 6 or more years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.
• Expertise in oncology highly preferred.

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.

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