Senior Director Clinical Safety MD

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 280,000 - 467,000; Full time

Job summary

Daiichi Sankyo US seeks a Sr. Director, Clinical Safety to lead integrated risk management strategies for Development Sankyo’s compounds, coordinating with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other groups to optimize benefit-risk from discovery through commercialization.

The role requires strong leadership to guide physicians and scientists, review trial and post-marketing data for safety signals, and lead safety-related regulatory interactions.

Qualifications

• MD Board certification or eligibility required.
• 6+ years of experience in the pharmaceutical industry, regulatory agency or academia with exposure to drug development, clinical pharmacology, and/or epidemiology.
• Experience in clinical development, submission and post marketing is strongly recommended.

Responsibilities

• Lead and medically-direct a team of physicians and scientists across development stages.
• Represent CSPV on Global Product Team and cross-functional groups for safety leadership.
• Identify safety signals from clinical trials and post-marketing data and manage risk.
• Define and implement risk management strategies across the product lifecycle and ensure timely safety deliverables.

Skills

Leadership

Safety analysis

Education

MD Board certification or eligibility

Job description

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).

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 is required Experience in clinical development, submission and post marketing, is strongly recommended.

Physical Requirements

N/A N/A% of the time.

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.

Salary Range

USD$280,350.00 - USD$467,250.00