Shire Senior Scientist- Pharmacology in Lexington, Massachusetts
The candidate will be a key contributor to research and early development programs at Shire. The candidate will collaborate closely with colleagues from research and non clinical development to develop pharmacology assay that highlight efficacy and pharmacokinetic/pharmacodynamic relationships of investigational compounds from multiple therapeutic modalities as they move through the discovery and development process. Additionally the candidate will utilize these data to provide submission-ready documentation for the pharmacology components of regulatory submissions.
Responsibilities (% of time):
Serve as non clinical pharmacology representative on discovery and development teams and sub teams.
Design, manage, analyze, review, summarize, interpret and report pharmacology studies to support ongoing programs.
Review and approve pharmacology study protocols, reports, associated non clinical summaries, sections and associated documentation, as well as abstracts and manuscripts for publication.
Provide scientific/technical due diligence support for business development activities as required.
Prepare for and participate in regulatory authority interactions as required.
Bachelor’s/Masters or PhD in Pharmacology or a related subject
5-10 years of industry-related experience in Pharmaceutical or Biotechnology field
Hands on experience in all aspects of pharmacology study conduct
Experience in outsourcing and external oversight of pharmacology studies at qualified suppliers
Experience with both small and macromolecular/biologics is desirable
Experience with animal models of GI and/or inflammatory diseases a plus
Fluency in spoken and written English is required
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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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.