At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

JOB DESCRIPTION:

Abbott Molecular has a new opening for Director Clinical Research located in Des Plaines, IL.

This position will manage Clinical Research professionals encompassing Clinical Affairs, Clinical Science, Clinical Biometrics (Statistics), Clinical Safety, Clinical Quality, and/or Clinical Project Management. He/she is responsible for the conduct of Clinical Research and the preparation of product submissions for U.S. and non-U.S. regulatory agencies through the Clinical Research Organization. Assures the long-term effectiveness of the organization and ensures that the needs of the division with respect to Clinical Research are met. Establishes long range plans and goals/functions and is responsible for the implementation and maintenance of the clinical research-related policies, processes and procedures related to their respective functional areas.

Core responsibilities include:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Provides significant and meaningful Clinical support to business unit leaders.
• Work and interact with key clinicianxternal to the organization present the division and Clinical Research in a positive manner to external contacts/KOLs.
• Develops internal teams, provides leadership and guidance to the larger Clinical organization; mentors, coaches, develops their employees worldwide.
• Provides strategic guidance to Quality.
• Manages cross-functional teams within the Clinical Research organization. Direct the design, planning, development and monitoring of all clinical evaluation projects or clinical studies as directed by your manager. Interact and lead scientific, clinical, and business activities at trial sites for the division.
• Direct team to ensure that clinical studies and/or clinical evaluations of those products determined to satisfy medical needs and/or commercial potential are conducted.
• Take the lead role in the development of the clinical planning and/or strategy. Define the clinical plan by establishing the appropriate clinical protocol for the desired product claim or indication.
• Establish and maintain appropriate systems to ensure adherence to ICH/GCP, risk management, and/or quality system guidelines including training and successful results from independent audits.
• Generate clinically/scientifically sound statistically analyzed data to confirm performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements.
• Review the clinical studies sections for regulatory submissions to ensure adequacy of support for all claims pertaining to safety, efficacy, clinical performance and Independent Review Board or ethics committees. Prepare quality regulatory submissions for U.S. and non-U.S. regulatory agencies.
• Provide compliance guidance on the conduct of clinical research, risk management, and/or clinical evaluation division-wide, for developing and overseeing a quality training program and for compliance in all audits of the Clinical Research organization.
• Represent the Division's clinical research programs and results at Global Regulatory Agency meetings, Advisory or Panel Committee meetings and in discussions with senior management and trade meetings.

Minimum Education:

Bachelors degree with 15+ years related work experience or equivalent combination of education and experience; or Masters degree with minimum of 10+ years of related work experience or equivalent combination; or PhD. or Medical Degree (MD) with 6+ years of related experience. Advanced degree, PhD. or Medical Degree (MD) strongly preferred.

Minimum Experience/Training required:

Candidates must possess skills which span both science and business and have a thorough understanding of the scientific method as they apply to the design and execution of adequate and well controlled evaluations of new products. Excellent written and communication skills.

Polished presentation skills are important as this position may be asked to represent the company to various regulatory agencies.

JOB FAMILY: Clinical Affairs / Statistics

DIVISION: AMD Molecular

LOCATION: United States

Des Plaines : DP01 Floor-2

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 20 % of the Time

MEDICAL SURVEILLANCE: Yes

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf