Friday, October 30, 2015

Senior Director US Clinical Research Neurology Lundbeck Chicago

Job Description
The company seeks a highly qualified and motivated individual to be a senior member of global, cross-functional teams developing new therapeutic entities for CNS, particularly in the field of movement and neurodegenerative disorders, including Parkinson’s disease and Alzheimer’s disease. The individual who assumes this high-visibility position will interact with multiple levels of management within various functions across the Lundbeck US and global organization

Essential Functions
Provides US strategic leadership to development programs for movement and neurodegenerative disorders, based on the candidate’s extensive clinical and scientific knowledge and clinical research expertise
Works collaboratively with global cross-functional colleagues to:
Develops and executes clinical development plans that will successfully transition compounds from discovery to full development, and subsequently to life cycle management
Ensures the optimal planning, implementation and interpretation of clinical studies, including direct participation in synopsis/protocol development, study awareness, study conduct, site interactions, data analysis, writing of final reports and submission of regulatory documents
Further develops and maintains effective relationships with thought leaders, consultants and investigators across the movement and neurodegenerative disorder scientific community, especially Parkinson’s disease and Alzheimer’s disease
Represents the company appropriately and communicates effectively at scientific, medical, industry and regulatory meetings
Supports public policy and patient advocacy initiatives
Reviews business development opportunities, translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements
Complies with current local and international regulations, laws, scientific and regulatory guidances, Good Clinical Practices, and Lundbeck Operating Principles, policies and procedures


REQUIRED EDUCATION, EXPERIENCE And SKILLS
MD, MD-PhD, or equivalent
Board Certified/ Eligible neurologist with specialized training and expertise in the diagnosis and management of neurodegenerative disorders, including movement disorders
Well respected within the US neurodegenerative disorders scientific community, including movement disorders
Possesses insight and personal skills to fulfill senior role on project teams, including relevant strategic experience of clinical R&D in pharma/bioscience companies and/or contract research organization
Minimum 5 years bio/pharma industry experience, with substantial understanding of drug development process and demonstrable contributions in clinical research, such as developing and executing clinical development plans and protocols
Excellent team skills, including the ability to work effectively in a geographically diverse, matrixed organization
Strong communication and presentation skills in the English language
Highly motivated, self-driven and dependable


Preferred Education, Experience And Skills
Clinical, scientific and research experience in Parkinson’s disease and Alzheimer’s disease
Preclinical and translational research experience in neurodegenerative disorders
Demonstrated skills in FDA interactions


Travel
Willingness/Ability to travel up to 30% domestically
International travel is required
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