Senior Director, Clinical Safety MD

Daiichi Sankyo Co., Ltd.; Basking Ridge (NJ); On-site; USD 160,000 - 240,000; Full time

Job summary

A leading global pharmaceutical company is seeking a Senior Director of Clinical Safety to lead risk management strategies for development compounds. This role requires strong leadership and collaboration with cross-functional teams. The ideal candidate should have an MD and at least 6 years of experience in drug development or clinical pharmacology. Comprehensive responsibilities include directing a team of experts, analyzing clinical trial data, and engaging with regulatory bodies. This position offers a pathway to impact patient safety and drug lifecycle management.

Qualifications

• 6 or more years of experience in the pharmaceutical industry, regulatory agency or academia.
• Exposure to drug development, clinical pharmacology, and/or epidemiology required.

Responsibilities

• Lead and medically direct a team of physicians and scientists for a compound/product.
• Represent the CSPV on the Global Product Team providing safety leadership.
• Review and analyze data from clinical trials for prompt identification of safety signals.
• Lead interactions to ensure quality outcomes in risk evaluation and management.
• Define and implement strategies for managing risks throughout the product life cycle.
• Coordinate resources in developing safety evaluation documents on time.
• Participate actively in safety-related regulatory interactions.

Education

MD. Board certification or eligibility required

Job description

Job Title: Senior Director, Clinical Safety MD

Job Requisition ID: 1041

Posting Start Date: 3/26/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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

• 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

Education Qualifications
MD. Board certification or eligibility required

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 required

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.