Senior Clinical Scientist 1

Shire Pharmaceuticals, Inc.
Senior Clinical Scientist I

Founded in 1986, Shire Pharmaceuticals, Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.

Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our continued growth, we currently have a need for a Senior Clinical Scientist I in our Wayne, Pennsylvania location.

Description
Responsible for the planning, implementation and management of clinical research studies that may include Phase I through IV. However, this position requires specific experience in the design and delivery of clinical pharmacology studies to insure that expertise in human pharmacokinetics, pharmacodynamics, and pharmacology is represented on applicable teams. Manages clinical outsourcing to CROs and other clinical vendors such as labs, IRBs, etc. Under supervision, authors protocols, informed consent forms, sections of investigational drug brochures and oversees study report writing.

Key Responsibilities
? May contribute to the clinical development strategy of R&D projects
? Provides Clinical Pharmacology input to Clinical Development plans and study designs
? Invites and assesses proposals from CROs and makes selection recommendations and creates contracts and/or work orders.
? Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.
? Responsible for planning and conducting investigator's meetings. May present information at the meeting.
? Oversees and monitors the management of clinical studies, which includes production and approval of a Clinical Monitoring Plan, by regular investigator site / CRO / clinical laboratory contact.
? Responsible for the clinical review and approval of Case Report Forms and the development and approval of corresponding completion guidelines.
? Develops and monitors budget for clinical development program and may negotiate budgets and contracts with CROs, investigative sites and vendors
? Negotiation of resources for the experimental medicine component of the project
? Oversees the management of CRO activities and other clinical vendors to ensure the quality is consistent with Shire requirements
? Identifies and contracts with specialized vendors for assays and analysis of samples and reporting -Ensures regular communication of clinical trial issues and progress to the Shire clinical team.
? Under supervision authors protocols, ICFs, sections of investigator brochures and oversees study report writing. Coordinates the on-schedule delivery of clinical trial supplies in collaboration with Pharmaceutical Sciences.
? Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities May mentor other Clinical Scientists.
? Responsible for liaising and coordinating with document specialists regarding study files.


Education and Experience Requirements
? Must have background focus in early phase studies!
? Bachelor's degree or nursing qualification is required. Scientific/health care field preferred, but not required.
? Generally has at least 5 years of diverse clinical research experience within a pharmaceutical company or CRO or similar organization.
? Must be able to create protocols and informed consents.
? Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.
? Working knowledge of project management software or tools.
? Must be able to independently present complex information to Shire management, CROs and the medical community.
? Proven ability to manage and communicate effectively with research vendors including negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
? Expertise in financial budgeting and forecasting or reporting is a must. -Demonstrated ability to prioritize multiple projects.
? Proven ability to independently resolve problems.
? Requires strong attention to detail and the ability to establish priorities schedule and meet deadlines.
? Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
? Ability to work independently, take initiative and complete tasks to deadlines.
? Ability to work successfully within a cross-functional team.
? Demonstrated ability to motivate & mentor staff.
? Excellent written and oral communication skills.
? Displays a high level of professionalism with vendors, external contacts and individuals at all levels of the organization.

To create a profile and apply online, go to http://v2.projectix.com/shire/jobboard/NewCandidateExt.aspx?__JobID=1044 Additional information can be found at www.shire.com

Shire is committed to providing high quality, competitive and appropriate health care benefits for employees and their families.

Shire is an Equal Employment Opportunity and Affirmative Action Employer.