| Job Description | Description
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Overview of Clinical Development
The Clinical Development group at Alkermes is located in Waltham, MA. Functions include Clinical Science, Clinical Operations (Trial Management, Data Management & Programming, and Medical Writing), Translational Medicine (including Pharmacology), Drug Safety and Pharmacovigilance, and Statistics. The group is tasked with designing and conducting clinical trials (Phases I-IV; domestic and international) aligned with corporate strategy and analyzing and communicating study results.
Frequent collaboration and excellent working relationships with various internal groups, including Preclinical Scientists, Regulatory Affairs, Business Development, and New Product Planning give Clinical Development input at all stages of drug development. Clinical programs are developed in conjunction with input from external subject matter experts and consultants, and are executed through partnerships with clinical research organizations.
Clinical Development is composed of a hands on group of dedicated professionals. Team members function with a high degree of personal accountability for the success of aggressive clinical programs and timelines. We have ongoing and planned clinical programs in Phases I-IV, primarily in psychiatry.
Alkermes is excited to add a highly motivated, experienced pharmaceutical industry physician to their Clinical Science Department to lead development efforts for their growing Neurology franchise. The position, reporting will be responsible for advancing the company’s novel programs within the Neurology franchise with a current focus in multiple sclerosis and pain. This will include planning, implementing and directing global clinical research programs across all phases of development. In addition, the new Senior Medical Director will be integral in advancing early stage compounds into the clinic.
ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS). With properties designed to enable improved flexibility in the development of extended-release formulations, ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and to offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA®. |
| | Company | | Alkermes | Job Code | | State or Province | | Massachusetts | | |
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