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. Requirements:
- 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
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.