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Shire Clinical Development Scientist in Lexington, Massachusetts
Collaborates 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 therapeutic area(s) are coordinated and consistent; Provides scientific advice within Shire R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific and clinical development expertise and providing guidance in support of brands and product launches.
Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs.
Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
Participates in drug safety surveillance for Development projects.
Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
Education and Experience Requirements
Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
Significant experience (12+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization.
Demonstrated ability to collaborate in a matrixed environment
Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
Experience in designing and conducting Phase II-III clinical trials; and/or
Significant late-stage development research
Other Job Requirements
Availability to travel approximately 25% of time.
Availability to participate in early or late meetings/teleconferences.
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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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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.