Job Summary

The Sr. Director, Clinical Safety, 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).

Job Description

Responsibilities

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).

Responsibilities Continued

Qualifications

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 is required (board certification or eligibility)

 

Experience Qualifications:

• 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.

 

Travel: Some travel both domestic and global will be required.

Additional Information