In early 2015, Actavis completed the acquisition of Allergan. This combination united two growing, successful and profitable companies into a unique, global pharmaceutical company and a leader in a new industry model - Growth Pharma. In June 2015, the combined company changed its corporate name to Allergan plc and its stock ticker to NYSE:AGN.
Today, our nearly 30,000 talented global employees are creating an unrivaled foundation for long-term growth. We combine highly regarded brands and a best-in-class generics business with an enviable pipeline and lean, reliable operations to drive value for customers.
Join one of the world's fastest growing specialty pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of stretch assignments and opportunities to step into the spotlight.
The role of the Senior Clinical Scientist is to guide and participate in all aspects of clinical development and study management under the direction of the study director, which includes providing logistic and scientific support to planned and ongoing Phase II-IV clinical trials. Will support more than one clinical protocol. Work cross-functionally to ensure alignment across studies and to achieve the corporate objectives for programs.
Main Areas of Responsibilities
• Manage and monitor the progress and deliverables of clinical trials through the clinical team's regular contact with sites/Regional Site Managers/vendors, standard and ad-hoc tracking tools, and site/project status reports.
• Actively contribute to the design of clinical protocols. Author/oversee/review study documents (e.g. synopsis, protocol, informed consent, investigator brochures).
• Review the monitoring plan, data management plan, and statistical analysis plan.
• Management of study budgets for clinical programs. Track and manage site budgets efficiently and provide timely resolution to financial inquires.
• Support site feasibility and the identification/selection of qualified investigators and study sites in collaboration with Global Monitoring/Clinical Operations.
• Support the planning of investigator meetings with Meeting Planning. Develop and deliver study specific training presentations as needed.
• Interact with PR&D to ensure adequate clinical supplies for the clinical trial. Oversee the shipment of drug supply, packaging, and labeling.
• Monitor and review clinical data for trends/errors during the course of the study.
• Identify potential clinical data issues and provide management with feedback to remediate issues.
• Collaborate with the Study Physician and Global Drug Safety in the review and management of safety related issues and serious adverse events.
• Generate and oversee clinical queries in EDC when needed.
• Manage interactions and drive results of vendors and CROs for studies outsourced.
Bachelor's or advanced degree (Master's, PharmD, PhD) in life sciences/health-related field
Min. 5 years of drug development experience in the pharmaceutical industry or CRO
Demonstrated experience supporting and managing the development, implementation, and completion of clinical trials and/or programs
Experience with Phase II-IV clinical trials
Expertise in specific therapeutic area or broad scientific/medical knowledge is preferred
Some document authorship experience (e.g., protocols, study reports, manuscripts)
Site/vendor management and data review experience
Project management experience is preferred
Supervisory experience is a plus
Prior field monitoring experience/background is a plus
Experience with CROs and working on global studies is a plus