Vice President, Global Team Lead Oncology R&D in Bernards, NJ at DSI

Date Posted: 5/16/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

SCOPE AND RESPONSIBILITIES:

The Global Team Leader (GTL) for the U3-1402 project is a senior, cross-functional leader in Daiichi Sankyo’s Global Oncology R&D organization. The role reports to the Global Head, ADC Task Force.

The Oncology GTL is directly responsible for conceiving, designing and implementing product development strategy and delivery for U3-1402. The GTL has senior accountabilities that are critical to the delivery of U3-1402’s development goals. These include:
  • Creating and leading a high performing, cross-functional project team of accountable global senior leaders which is responsible for the identification and articulation of a competitive, efficient and effective development strategy and execution for U3-1402. At Daiichi Sankyo, the engine of development is the cross functional, empowered and agile global project team, directly accountable to global Development governance. 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 U3-1402.
    • Creation, maintenance and update of U3-1402 Integrated Product Development Plans, Target Product Profiles and Target Product Claims, and presentation of product development plans and budget to internal governance and review Boards.
    • Delivery with excellence, innovation and aiming for perfection of critical development plans within tolerance on value, time, cost and quality.
  • Ensuring that creative, innovative as well as practical approaches are deployed to U3-1402 development plans to maximize its performance and potential.
  • Maintaining with the highest integrity and ethics, a drive for performance and competitive posture.
  • Driving maximum value for products in development contributing to DSI value targets through life cycle management and rich external science plans, including translational science, biomarker programs, label expansions, combinations and new indications.
  • 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, project management capability and robust peer review of projects and products.
    • Providing regular status updates to governance on progress, risks, opportunities and challenges, and pertinent changes in the external environment.
    • Approval for all external information on the U3-1402 program, including publications, regulatory documents, clinical trial registers, data release, etc.
    • Managing and protecting the Intellectual Property (IP) assets of the Company’s ADCs in consultation with IP and legal experts.
  • Leading personal and corporate relationships 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.
    • Ensuring the protection of subjects in clinical trials, ethical conduct of all clinical trials and overall benefit-risk assessment.
  • Managing development budget to ensure planning and spending is within approved budgets and consistent with established operating expense goals and in line with DSI’s processes.
  • Providing best practices to DSI’s overall Oncology development strategy and drug development goals. Influencing their adoption and facilitating cross-functional implementation across the Organization.
  • Ensuring development and effective implementation of high quality clinical protocols, identification of appropriate clinical sites, and oversight over study conduct, data management, statistical analysis, and report preparation.
  • 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.
  • Safeguarding and ensuring continuous improvement of quality of preparation, conduct, monitoring, data management, and reporting of clinical studies. Maintaining a Quality Management System including a system of policies, SOPs, working guidelines to regulate all GCP relevant activities, contribution to training of internal personnel involved in clinical study activities, structured sponsor oversight of all collaboration partners in GCP relevant areas. Will also ensure schedule of study specific and system/process audits based on documented risk assessment, and timely critical feedback and implementation of corrective and preventive measures to address quality deficiency findings.
  • Lead individuals in the cross-functional team with the aim of contributing to optimal individual development and accomplishment.
DESIRED EXPERIENCE/PERSONAL ATTRIBUTES:
  • Substantial knowledge and experience of the drug development process and successful leadership of cross-functional, teams supporting major global Oncology development programs.
  • Successful track record of designing and leading global development plans to advance programs from development to successful registration.
  • Track record in successfully leading Oncology programs focused on innovative, next-generation therapies and approaches.
  • Significant scientific and/or clinical credibility, including understanding of translational science.
  • Track record of successfully designing and implementing development methodologies supporting first-in-class, next generation therapies.
EDUCATION:
  • MD, PhD, or MBA with substantial industry-based development experience in Oncology, Board certified oncology MD preferable but not necessary. An impeccable oncology clinical and medical expert with proven credibility and a track record of successful drug development.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.