The Global Development Lead will be responsible for defining and executing on the development strategy of two assets at different development stages. Reporting to the Vice President, Obesity Development Area Head, the successful candidate should have demonstrated proficiency in leading and/or supporting development programs, cross-functional collaboration, and represent program(s) externally. ROLE RESPONSIBILITIES Lead product specific Global Development Teams Serves as the subject matter expert on clinical issues Work across the organization and on the cross-functional Global Development Team to lead, develop and execute the clinical development plan of Obesity related assets in late-stage clinical development. Endorses clinical decisions in advance of senior management reviews or governance bodies Provide oversight of medical director(s) and clinicians Accountable for the clinical development strategy, trial design, execution, and delivery of trial results Accountable for integrating regulatory, statistical and other internal and external stakeholder input into study designs Serves as primary interface with Development Review Committee Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports Oversee the evaluation, interpretation, reporting and presentation of study data Accountable with safety for clinical evaluations and safety decisions Accountable with clinical pharmacology for defining and identifying optimal dose and schedule selection Accountable with regulatory for health authority interactions May participate in evaluating business development opportunities BASIC QUALIFICATIONS Advanced degree with relevant clinical/industry experience . 12+ years industry experience Experience in leading NDA, BLA or MAA in the cardiometabolic space Competency Requirements Management experience - Able to work in a highly complex matrixed environment and able to influence cross-functional teams. Leadership - Persuasive and effective leader of staff Influencing - Able to manage and motivate internal teams on clinical trials. Conflict Management - Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and settle disputes equitably; prepared to take responsibility for a decision made and support this, even though it may be unpopular. Team Building - Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team. Accountability - Take personal responsibility for results, pushing self and others to exceed goals and deliver results. Change agile - Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed