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Global Team Lead Oncology R&D Vice President
Location : New Jersey, Basking Ridge
Refer job # OTAK339354

Job Responsibilities and Requirements: 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.



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