Director, Clinical Development - Diabetes and Metabolism

The Director, Clinical Development is a critical role within Daiichi Sankyo's Clinical Development group for implementation of clinical development plans for the assigned global and regional compound development projects. This position provides rigorous clinical and scientific leadership and operational excellence to translate scientific data into executable clinical development plans for compounds in development and transform development compounds into medicines of values. The successful candidate will contribute to the development of development strategy, clinical trial design and implementation, be responsible for leadership and medical oversight of clinical trial conduct, and contribute to data analysis, interpretation, writing of reports and regulatory submission documents, and dissemination of trial results. · Position is located in Daiichi Sankyo's US DSPD office in Edison, NJ · Reports to Executive Director, Clinical Development KEY RESPONSIBILITIES AND ACCOUNTABILITIES · Clinical leadership for compound development strategy Represent Clinical Development function by participating and contributing clinical leadership in multi-functional project teams as assigned, and be responsible for creation and updates of an efficient compound development plan consistent with clinical, regulatory and commercial strategies. · Leadership and oversight on clinical trial design and execution As a Clinical Study Leader, provide leadership and oversight for clinical trial planning, study design, and development of study protocol, investigator brochure, and other relevant documents. Lead the study team to successful conduct of clinical trials, and provide oversight to clinical operation and CRO. Contribute to data analysis, interpretation, report writing, and dissemination of trials results and publication. · Medical Monitor oversight and scientific expertise to assigned clinical trials Serve as the sponsor medical monitor for investigator sites and CRO on protocol issues. Be accountable for study-level medical and safety decisions and participate as sponsor medical lead in Safety Monitoring or Adjudication Committees. · Clinical and clinical development leadership for regulatory submissions Contribute to clinical components of regulatory strategy in support of compound development, and contribute to clinical and clinical development sections of regulatory submission dossiers by authoring and reviewing of pertinent documents. Attend and participate in regulatory meetings. · Therapeutic area scientific and clinical expertise Act as the internal therapeutic area expert, develop and maintain thorough understanding of disease states, treatment, unmet needs, competitor landscape with diabetes and metabolism. Provide therapeutic area expertise in support of o Clinical Pharmacology, Regulatory, Medical Affairs and New Product Planning groups o In-licensing evaluation o External partners, consultants, and advisors · Education o MD, US Internal Medicine training and board certification or eligibility. Subspecialty training in Endocrine ability to anticipate future trends, needs and consequences o Innovative and global thinking o Ability to work collaboratively in a organization with highly matrixed cross-functional teams o A personal style that contribute to an environment to encourage active exchange of ideas and scientific challenges o Cross-cultural sensitivity suitable for an inter-digitated East-West global team environment