Head of Medical Safety Oncology Assets at Daiichi Sankyo, Inc.

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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

• The 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 for certain safety-related issues, approving various safety documents. In addition, this position interacts with internal stakeholders and provides mentorship in talent development among CSPV organizations working with Head of CSPV.
• Overall, this position has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program in CSPV organization.

Responsibilite

• Leading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and risk management activities for his/her portfolio. Serves as the company’s senior representative with key high-level internal and external stakeholders on important drug safety issues supporting Global Medical Safety Lead. Responsible for safety governance/oversight of Clinical Safety and risk management activities. Providing adequate and proper management of resources to support all projects and maintain business continuity.
• Managing productive cross-functional Medical Safety collaborations within and across line functions, e.g. Clinical Development, Medical Affairs, Regulatory Affairs, Clinical Operations. 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.
• Create and align processes that address global CSPV objectives by working with CSPV senior management and leadership. Provide coaching, motivate, direct, and foster teamwork, lead cross-functional, multi-cultural teams to develop talents among CSPV organization. Lead special projects cross-functionally as needed
• Enhancing the scientific and clinical experience for all CSPV staff through continuous training and coaching. Building the talent pipeline, attracting, retaining, and developing talents within CSPV.

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 is required.

Basic Qualifications

• At least 15 years of professional drug development experience in a major pharmaceutical company, including at least 7 years in global medical safety.
• Oncology expertise is strongly preferred.
• Experience responsible in leading roles in clinical or safety through complete submission process & in submission of data to health authorities.
• Proven strong leadership in coaching, mentoring, fostering teamwork with experience in leading multi-cultural, cross functional teams.
• Ability to maintain and develop effective work relationships with subordinates, superiors and peers.
• Strong negotiation and conflict management skills.
   

Travel

• Must have the ability to travel domestic and global up to 10%

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.