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Director, Quality Assurance and Regulatory Submissions - Biologics Product Development

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Executive
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Biologics Development 710928
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128981 Requisition #
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POSITION SUMMARY
The Director will:
  • be part of the Product Development senior staff that defines the strategy and oversees the execution of selecting and developing the group’s portfolio;
  • make final disposition decisions on all clinical products and must demonstrate a balance between information gathering from scientific experts with a mandate to protect patient safety and health;
  • Lead both the strategic and operational aspects of Regulatory Science.
BIOLOGICES PRODUCT DEVELOPMENT DEPARTMENT

The Biologics Product Development Department is part of MD Anderson’s Therapeutics Discovery and Development Division, which is the link between the basic science and the translation, driving the future of new targeted, immune- and cell-based therapies. This structure and collaborative approach allow the team to work with agility, bringing novel medicines from concept to clinic quickly and efficiently – all under the same roof. The goal will be to develop industrial caliber biologics with a commercial horizon within the innovative environment of an academic cancer center. This unique approach has created a biotech-like engine within the walls of the nation's leading cancer center to bring life-saving medicines to our patients more quickly and effectively.

CANDIDATE QUALIFICATIONS
  • BS/MS degrees in scientific fields
  • 12+ years of experience in Quality and Regulatory Submissions
  • Experience in the biotech, pharmaceutical or related industry
  • Experience leading strategic and operational aspects of Regulatory Science
  • Leadership capabilities to define, populate, manage and develop a team
  • Demonstrated ability to collaborate effectively in a multi-disciplinary team
 
TOBACCO-FREE HIRING

MD Anderson Cancer Center is committed to encouraging good health and staying true to our mission to end cancer.  As part of its efforts to achieve these goals of a tobacco-free hiring process, if you are offered a position at MD Anderson Cancer Center, you will be subject to a Pre-Employment Drug Screen for tobacco compounds in compliance with applicable state laws.

 

EQUAL EMPLOYMENT OPPORTUNITY

Diversity and inclusion at MD Anderson are not just important; they are essential. Workforce diversity is one of its greatest strengths and keys to success in our mission to cure cancer. We take an expansive view of diversity, considering differences in race, ethnicity, sexual orientation, gender and religious beliefs, as well as communication styles, thought, skill and ambition.

 
 

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