Job Description
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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
The Clinical Safety Executive Director (ED) is responsible for the overarching, global safety strategy and risk management activities, across the lifecycle, for his / her assigned product(s) or designated therapeutic area(s).
To successfully accomplish this, the ED recruits and develops direct reports, identifies and selects resources / tools to facilitate risk management, effectively interfaces with key high-level internal and external stakeholders and expertly oversees regulatory reports (such as RMPs and periodic reports) and the safety content of other relevant documents (such as the IB, informed consent document and protocol), and new and / or supplemental indication submission activities.
The ED independently addresses the most complex safety issues and may act as a final decision-maker for Clinical Safety and Pharmacovigilance.
Overall, the ED has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program.
Responsibilities
Overall : Drives the safety strategy for the development and lifecycle management of assigned product(s) or TA(s). The ED is ultimately responsible for Clinical Safety governance, safety surveillance and risk management activities for his / her portfolio.
Oversees the development, maintenance and submission of relevant RMPs and spearheads REMS activities for designated products.
Works with CSPV senior management and leadership to create and align processes that address global CSPV objectives. Represents CSPV in cross-functional meetings and presentations including with colleagues in Clinical Development, Regulatory Affairs, Quality, etc.
Clinical Study Safety : Provides strategic input on safety surveillance and risk management for clinical protocols. Ensures safety content of the IBs and ICFs are robust and consistent across studies / programs.
Oversees the inclusion of comprehensive safety assessment plans in the clinical development plans. Supports the implementation and oversight of relevant safety committees such as DSMBs and adjudication committees.
Provides safety advice on the design of post-approval studies. Prepares expert analysis, interpretation and communication of safety data arising from clinical studies.
Ensures the integration of all relevant sources of data while doing so.
Post-market Safety : In addition to the Clinical Safety skills, the ED formulates strategic approaches to signal detection, evaluation, communication and mitigation using spontaneous datasets and continues to be primarily responsible for the final comprehensive assessment and interpretation of safety data.
Ensures that core safety positions and communications are consistent and globally aligned. Anticipates regulatory responses to emerging safety issues and provides strategies to address these.
Works closely with others to identify / obtain innovative signal evaluation tools that are useful for global assessments.
Risk Mitigation & Communication : Formulates strategic approaches for risk mitigation for global products / TAs and ensures these activities are properly carried out.
Serves as company expert for risk mitigation and oversees the global communication of important product safety information.
Oversees the identification and retention of external partners / CROs for effective risk mitigation for assigned products.
Reports and Submissions : Oversees safety sections for NDA submissions. Effectively drives TA products through the approval process and serves as lead CSPV representative for internal safety and external regulatory interactions associated with NDA / MAA approval.
Has overall responsibility for the RMP submission and adheres to associated SOPs and regulatory guidance. Ensures the accurate content and quality of periodic safety reports (such as the DSUR and PBRER / PADER).
People Management : Recruits direct reports and trains and develops them using individual development plans and routine day-to-day manager / employee interactions.
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 or DO or International equivalent degree required
- Clinical experience with patients required
- Board certified or eligible preferred
Experience Qualifications
- 10 or More Years of experience in Pharmacovigilance and / or Clinical Safety preferred
- Experience managing people preferred
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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