Vice President, Head of Late Stage Clinical Development

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

As Head of Late-Stage Oncology Clinical Development you will have full accountability for the success of the Enhertu, Datopotamab deruxtecan (Dato-Dxd) and Patritumab Deruxtecan (HER3-DxD) clinical programs \ including the design and delivery of Clinical Development Plans (CDPs). You will leverage your deep knowledge of the field of oncology and global clinical development to progress the company's three late-stage antibody drug conjugates (ADCs) either towards successful life-cycle management in the case of Enhertu or towards registration in the case of Dato-Dxd and HER3-Dxd. You will be accountable for the clinical strategy but will also be expected to play a hands-on role in the operational execution of these programs. You will collaborate with internal and external R&D partners to define clinical development strategy, innovative clinical trial design and translate scientific ideas to proof of concept in target populations. You have a keen focus on patient needs and an understanding of the connection with commercial value and are able to translate this into effective clinical trial design and execution. You will play an important role internally and work closely with senior leadership in developing the clinical strategic direction of these three ADCs and presenting these ideas to the leadership team. You will be expected to create a positive working environment and culture, facilitate a smooth interaction between teams and departments, and work cross functionally to execute and thus deliver the strategy. You will also be expected to supervise, manage and lead the Global Clinical Leads (GCLs), who are the clinical leaders of the late-stage cross-functional asset teams You will also play an important external role for the organization ensuring a close working relationship and partnership with investigators, trial sites and ensuring a close collaboration with Daiichi-Sankyo collaborators and the medical and scientific community.

Responsibilities:

• Set the direction and lead the implementation of the Clinical Development strategy for Enhertu, Dato-DxD and HER3-Dxd. Achieve and maintain leadership in clinical development strategy. Develop and propose a range of strategic options with best registration path to secure governance approval for the projects. In addition, support the solid tumor Disease Area Strategy Teams in developing cross asset strategies for our ADC programs.
• Serve as a member of Joint Development Committees with AstraZeneca for the Enhertu and DatoDxd programs. Co-lead the JDCs while representing the strategic interest of the Daiichi Sankyo global project teams and governance bodies. Serve as a member of Joint Steering Committees with academic collaborators as needed to support the progress of the development of Enhertu, DatoDxd and HER3Dxd.
• Partner closely with the Global Regulatory Affairs organization to ensure the clinical strategy alignment with the regulatory strategy for the three late-stage ADCs Accountable for all clinical aspects of regulatory submissions.
• Partner closely with Global Clinical Operations to ensure the execution of the oncology development portfolio. Help to drive operational excellence and to maximize the clinical portfolio value via the effective management of quality, cost, time and risks.
• Maintain a solid knowledge of the main competitors in each clinical program and within the broader field of oncology. Build external network and collaborations to secure clinical development excellence. Build and maintain solid relationships with top international key experts and scientific decision-making professionals. Build a network of relationships within the oncology space, including investigators, and other clinical external stakeholders. Maintain efficient contact with regulatory authorities and bodies, dealing with all feedback and comments.
• Develop and build dynamic, innovative, and science-driven teams. Ensure late-stage oncology clinical development has strong talent and a highly effective culture. Ensure departmental goals and targets are achieved.
• Partner with business development and conduct due diligences.
• Partner with the OBU to ensure the effective uptake, access and commercialization of the portfolio.
• Represent Daiichi-Sankyo externally as required.

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 with board certification in oncology or related field required Experience.

Qualifications:

• 10 or More Years Leadership experience in the biopharma space with significant experience in Oncology Development required.
• 10 or More Years Track record of success in developing oncology medicines and gaining both regulatory and re-imbursement approval required.
• 10 or More Years Leading drug development teams across a global matrix required.
• 10 or More Years Strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills.
• Ability to influence internal and external stakeholder groups, especially global regulatory and governmental authorities required.
• Ability to Travel up to 20% domestic or international travel where is needed.

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.