Associate Director, Clinical Safety Scientist

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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 15,000 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

This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk profile throughout product life cycle. Collaborates with the PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, oversees team's workload, anticipates potential issues and works towards resolving issues, and escalates and communicates issues, as appropriate. Oversees or leads the coordination of Safety Management Team (SMT)/Product-level safety meetings, maintains roster, calendar, and minutes, and communicate materials, in support of the PSL. Independently evaluates safety data of any source to identify potential safety signals and performs safety analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate forums, including SMT or other cross-functional teams. Oversees or tracks safety signals in the global electronic signal tracking tool. Collaborates with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and local country submissions. Collaborates with PSL/Clinical Safety Physician(s) and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD). May oversee multiple simultaneous submissions to ensure harmonized approach of safety sections of the submission dossier, where applicable, and to ensure timelines and business objectives are met. Subject matter expert (SME) in 2 or more focus areas. May supervise a team of Clinical Safety Scientists for assigned product(s),or serve as a preceptor for post-doctoral fellows. Provides guidance, and mentors and coaches junior Clinical Safety Scientists.

Responsibilities

Risk Management (Signal identification, evaluation, mitigation):

• This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk profile throughout product life cycle.
• Develops materials (presentation, safety analyses / evaluation, etc.) for SMT/Product-level safety meetings, including recommended safety actions, and communication and risk minimization plans.
• Authors or oversees the development of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs), for assigned product(s)
• Authors or oversees the development of the Safety Management Plan for assigned product(s)
• Independently evaluates safety data of any source to identify potential safety signals and performs safety analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate forums, including SMT or other cross-functional teams.
• Oversees or tracks safety signals in the global electronic signal tracking tool.

Safety Communication:

• Collaborates with PSL(s) or Clinical Safety Physician(s) for assigned product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings TFLs ), and other clinical study documents
• Authors or oversees the development of safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)
• Collaborates with PSL(s) and cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communication
• Ensures consistent and unified safety message throughout multiple documents
• CTD submissions/Others:
• Collaborates with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorisation Applications (MAAs), and local country submissions. Collaborates with PSL/Clinical Safety Physician(s) and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD). May oversee multiple simultaneous submissions to ensure harmonized approach of safety sections of the submission dossier, where applicable, and to ensure timelines and business objectives are met
• Subject matter expert (SME) in 2 or more focus areas
• Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as needed
• Acts as audit/inspection Subject Matter Expert (SME) for safety surveillance and risk management for assigned product(s), through inspection readiness preparation, and may serve as the primary or back-up SME, and may collaborate with team on CAPAs, including CAPA responses and approvals

Project Management:

• Collaborates with the PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, oversees team's workload, anticipates potential issues and works towards resolving issues, and escalates and communicates issues, as appropriate
• Oversees or leads the coordination of Safety Management Team (SMT)/Product-level safety meetings, maintains roster, calendar, and minutes, and communicate materials, in support of the PSL
• May oversee multiple simultaneous complex projects, ie, multiple submissions, to ensure harmonized approach of safety sections, where applicable, and to ensure timelines and business objectives are met
• People Management/Leadership:
  • May supervise a team of Clinical Safety Scientists for assigned product(s), or serve as a preceptor for post-doctoral fellows
  • Provides guidance, and mentors and coaches junior Clinical Safety Scientists

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)
• PharmD preferred.
• PhD preferred.
• Bachelor's degree in healthcare required.

Experience Qualifications:

• 3-5 years of proven experience with an advanced degree required.
• 6-9 years of experience with a bachelor's degree required.
• Clinical development or post-marketing experience to be able to apprehend safety context through the product life cycle.
• Understanding of Safety Risk Management internal and external environment, including applicable regulations and guidance's
• Ability to engage team and cross-functional team members to facilitate continuous flow of information to meet business objectives.
• Manages conflict and negotiates constructively.
• Ability to develop and build healthy working relationships to enable higher performance.
• Effective oral and written communication skills
• Demonstrated ability to handle more than one complex project simultaneously, prioritizing and recognizing key issues.
• Demonstrates effectiveness in working in a multidisciplinary and matrixed environment.
• Understanding of tools, standards, and approaches used to efficiently evaluate safety is desirable.
• Microsoft Word, Excel, PowerPoint skills, and Project management skills
• Able to work independently with minimal direct supervision.

Physical Requirements

• Global Travel 20% of 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.

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