Professor & Program Coordinator, Clinical Research; Consultant, Life Sciences; AttorneyThe focus of my career is innovation and integrity to produce results that improve people’s health. I have over 25 years of success working with regulatory agencies and a track record of defining and implementing development plans and regulatory strategies that move assets through all development phases. My background includes the scientific and legal credentials, experience, and skill set required to integrate business and clinical objectives for optimal regulatory outcomes. I am particularly strong in guiding drug development through all phases of clinical trials including multiple-markets and global submissions. As a dynamic learner and divergent thinker, I introduce disruptive innovation, integrate knowledge, and articulate technical issues for diverse audiences of peers and customers.SKILLS & CAPABILITIES:* Interfacing with clients and stakeholders to define, communicate, and manage project scope of work, strategy, timelines, milestones, and priorities.* Coordinating scientific, technical, and regulatory activities to achieve project milestones and deliverables.* Reviewing and managing deliverables for efficiency, quality, and compliance with contractual and regulatory requirements.* Contributing to business development by building client relationships, leveraging network of industry contacts, and expanding scope of work with existing projects.* Raising awareness of company R&D initiatives by presenting and publishing in industry forums.CORE COMPETENCIES:Program, Project & Portfolio Strategy Development & Management Issue, Crisis & Risk Management Regulatory Response & Submission Planning Global Submission Strategy & Execution Legal Research, Document Drafting & Review Negotiation Business Analytics & Data Visualization Capacity Planning Organizational Strategy Training & Development Cross-functional Team Leadership