Executive Director, Clinical Safety

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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

Job Summary:

Position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least one therapeutic area or a large, global Phase 3/4 program. This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this position regularly interfaces with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge. This position independently addresses the most complex safety issues and acts as the final decision-maker, approving various safety documents. Overall, this position has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program.

Responsibilities:

• Safety Expert - Overall: Serves as the safety expert for the TA or product and company expert on drug safety topics. Responsible for safety governance/oversight of Clinical Safety and risk management activities. Oversees RMP for a major product or multiples products within at least one TA.
• Safety Expert - Signal Identification: Formulates strategic approaches to signal identification, trains junior staff, and educates the company. Works closely with others to identify/obtain new signal identification tools that are useful for global surveillance.
• Safety Expert - Signal Evaluation: Formulates strategic approaches to signal evaluation and trains junior staff. Primarily responsible for the final comprehensive assessment of safety data. Works closely with others to identify/obtain innovative signal evaluation tools that are useful for global assessments.
• Safety Expert - 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 key regulatory interactions associated with NDA/MAA approval.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

• Requires MD degree
• 8 years of experience and board eligibility

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.

Job Title
Executive Director, Clinical Safety

City
Basking Ridge

Functional Area
CSPV

State
New Jersey