Reporting to the Process Optimization Team Lead, the Associate Director Innovation & Process Optimization is responsible for evaluating, developing, and implementing innovative processes and process optimizations for the clinical development team in collaboration with all functions of clinical development, other R&D functions and vendors to increase efficiency in all phases of clinical studies in the Global Clinical Development organization.
Works closely with the Clinical Operational Excellence Team to design and support optimum Clinical Development processes.
• Identify, assess, prioritize, and evaluate more efficient ways of working to achieve synergy savings and drive relevant projects
• Identify, assess, prioritize, and evaluate Innovation topics focusing on the rare disease patient population and drive relevant projects
• Build and maintain relationship with vendors and external organizations in support of implementation of new systems.
• Establish relationships and work with internal (OpEx team, CDO functions) and external (e.g. TAs, IT, Supply Chain, Quality, Safety, MA) stakeholders to identify and efficiently implement Process Optimization and Innovation projects
• Monitor industry trends and developments relating to their applicability and feasibility to Clinical Research with focus on study execution.
• Work closely with internal and external stakeholders to assess potential for improvement in the Clinical Development process chain that can be addressed by optimizing current processes or using new processes, tools, and technologies.
Education & Experience Requirements:
• Bachelor's degree in science, medically related field, nursing or business..
• 8 - 10 years of experience in global pharmaceutical, biotechnology or medical device industry directly related to the clinical development process.
• Experience defining clinical development project strategies and or developing successful solutions utilizing formal project management practices and processes.
• Current with industry developments, trends and opportunities, and best practices.
• Fluent in English both verbal and written communication.
• Experience leading continuous process improvement initiatives.
• University degree or equivalent in Biology, Chemistry or other life science, MBA or PhD
• Six Sigma certification or other formal project management training
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.