Executive Director, Global Team Leader Quizartinib
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.
The Global Team Leader, Quizartinib is a senior, cross-functional leader in Daiichi Sankyo's Global Oncology R&D organization. At Daiichi Sankyo, the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. Quizartinib is approved for R/R AML in Japan and has a global ph3 trial in front line FLT3 ITDm AML in progress with line of sight to global submission, should the Quantum-First data support it. Quizartinib is also in development for pediatric AML and has multiple collaborative research studies on-going to inform life cycle management. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. The Oncology GTL is the GPT Leader, directly accountable for conceiving, designing and implementing product development strategy and delivery. The GTL has end-to-end single point of accountability over the lifecycle of the compound. Acting as "CEO of the molecule", the GTL has accountability that far exceeds its direct span of control which require very strong cross-functional leadership abilities. The role reports to the Vice President, Head of Cancer Enterprise Alpha Portfolio.
- Creating and leading a high performing, cross-functional global project team composed of representative of asset/ compound lifecycle from research to post-marketing functions.
- Lead all GPT meetings, ensure team and cross functional alignment, positive dynamics and productivity. Ensure input from global functions and commercial regional entities are reflected into strategy and plans.
- The GTL ensures global project team's responsibility for the identification and design of a sound, overarching and competitive, product development strategy and execution to ultimately achieve global regulatory filing and ensure wide access of the compound. That strategy will provide for a differentiated, clear and sustainable platform of evidence generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety, data, CMC, IP, patient selection, commercial and other relevant functions in support of the compound.
- Design, maintenance and update of the compound's Integrated Product Development Plans, Target Product Profiles and Target Product Claims, and presentation of product development plans and budget to internal review Boards.
- Execution and delivery of development plans with speed and high-quality. Ensuring that creative, innovative as well as practical approaches are deployed to development plans to maximize its potential and value.
- Maintaining with the highest integrity and ethics, a drive for performance and competitive posture.
- Managing development budget to ensure planning and spending is within approved budgets and consistent with established operating expense goals and in line with DS's processes.
- Providing proactively regular strategic and tactical status updates to governance on progress, risks, opportunities and challenges, and pertinent changes in the external environment
- As a highly visible leader in the Daiichi Sankyo Cancer Enterprise (DSCE), contributing to the delivery of the comprehensive Oncology Research and Development portfolio to maximum value, including the identification and delivery of cross-portfolio opportunities, the development and growth of scientific leadership, cross-functional development acumen.
- Providing best practices to DS's overall Oncology development strategy and drug development goals. Influencing their adoption and facilitating cross-functional implementation across the Organization.
- Accountable for all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc.
- Accountable for protecting the Intellectual Property (IP) assets of the Company in collaboration with IP and legal experts.
- Leading personal and corporate engagement with external Key External Experts (KEEs) and research scientists, collaborators, and other external stakeholders.
- Collaborating with external partners to deliver existing commitments and to explore additional partnering opportunities.
- Accountable for ensuring the protection of subjects in clinical trials, ethical conduct of all clinical trials and overall benefit-risk assessment.
- Providing direction to clinical development in support of regulatory submissions and interactions including
preparation of study reports and integrated summaries for regulatory filings including responsibility for overseeing/authoring clinical documents, preparation and provision of medical expert presentations at health authority meetings and development of product labelling.
- Functioning as an expert Oncology liaison between the Company and leading academic specialists.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
MD, PhD, PharmD or MBA with substantial industry-based development experience in Oncology
10 years of experience in global drug development environment
An impeccable oncology clinical and/or medical expert with proven credibility and a track record of successful drug development, preference for late-stage/pivotal experience.
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.
Executive Director, Global Team Leader Quizartinib
Global Oncology R&D