Senior Associate Director, Clinical & Scientific Affairs

Our Culture - Come Discover Us
Boehringer Ingelheim is a family-owned company that is in the business of providing our customers with pharmaceutical and animal health products that significantly enhance their health and improve their quality of life. Our most important resource is our committed, creative and determined employees whose energy is focused on discovery, development and delivery of our innovative products to those who need them. The employees of Boehringer Ingelheim are our most important competitive advantage. Our global presence and thinking provides the opportunity for employees to work internationally and on teams, offering them visibility and the ability to influence the direction and outcome of critical projects. Competitive benefit and compensation programs reflect the Company's high regard for its employees and enhance each person's ability to balance the demands of work and personal responsibilities. Every employee at Boehringer Ingelheim contributes to the company's uncompromising commitment to quality in our products, excellence in our scientific pursuits and high ethical standards of behavior. The diversity of our employees makes it possible for us to craft unique solutions to today's complex business challenges. We are an equal opportunity employer. M/F/D/V.

Job Description
REQUIREMENTS:

* Must have an MD degree in Neurology - preferably in movement disorder.

* Prefer experience in clinical research - pharmaceutical industry preferred.

* Must have thorough medical/scientific knowledge of neurology.

Must have analytical skills and good oral and written communication skills.

DUTIES AND RESPONSIBILITIES:

* Responsible for conduct and/or management of clinical trials including protocol development, study conduct and reporting. Duties may include assignment as Team Member Medicine (TMM), Trial Clinical Monitor, and/or Local Clinical Monitor. Plans and implements clinical portion of Product Development Plan locally and/or on international level when acting as TMM. If TMM, may actively participate as member of Medical Sub team and may also participate in Clinical Expert Group. Also responsible for providing input on medical issues.

* Supervises appropriate clinical staff in execution of operational aspects of clinical trials/projects.

* Responsible for interpretations and summarization of clinical data and for documenting such information in medical sections of regulatory documents such as IND, IND annual reports, Clinical Trial Reports, NDA, and NDA annual reports. Provides medical judgment on safety sections. May also review labeling for marketed drugs, manuscripts, publication plans and press releases.

* Responsible for assuring adherence to governmental regulations and guidelines and BI SOPs in preparation, conduct and reporting of clinical trials. Also responsible for interpreting such guidelines to direct reports and investigators.

* Develops and maintains relationships internally with others involved in drug development process, and externally with investigators, consultants and contract research organizations. Interacts with marketing and other internal groups.