Daiichi Sankyo US
Senior Director Clinical Safety MD
Lead the development and implementation of integrated project/product risk management strategies for development compounds through the Safety Management Team framework. Serve as a safety leader across cross-functional teams, reviewing safety data, identifying and managing risks, and coordinating regulatory interactions throughout the product life cycle.
Key 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).
Required
- • MD Board certification or eligibility required
- • 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
Preferred
- • Experience in clinical development, submission and post marketing, is strongly recommended
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
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
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