Shire Associate Director, Clinical Scientist in Cambridge, Massachusetts

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Baxalta US Inc., a Shire Company for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION : Associate Director, Clinical Scientist

POSITION DESCRIPTION: Baxalta US Inc., a Shire Company, is seeking a Associate Director, Clinical Scientist with the following duties: support development and execution of medical and clinical strategy for Hemophilia products; collaborate with Global Development Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the Hematology therapeutic area are coordinated and consistent; assist in the review, analysis, and reporting of clinical trial data and review statistical analysis plans, clinical protocols, and clinical study reports for scientific and operational accuracy; provide scientific and clinical development support for Hemophilia products, provide input into regulatory questions, and run ad hoc searches and provide scientific advice within company R&D and other functions in support of product launches; participate in cross-functional team meetings and interact as needed with partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams; support drug safety surveillance for clinical development projects.

REQUIREMENTS: Doctorate (PhD) degree in Biological Sciences or related field plus 3 years related experience. Required skills: assist in the review, analysis, and reporting of clinical trial data and review statistical analysis plans, clinical protocols, and clinical study reports for scientific and operational accuracy; provide scientific and clinical development support for Hemophilia products, provide input into regulatory questions, and run ad hoc searches and provide scientific advice within company R&D and other functions in support of product launches; participate in cross-functional team meetings and interact as needed with partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams; support drug safety surveillance for clinical development projects.

Full time. $127,400 - $191,100/year. Competitive compensation and benefits.

Qualified applicants can apply directly to the Baxalta Website at: www.Baxalta.com. Please reference job #R0010867. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

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.

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.