Associate Medical Director (Schizophrenia) 9/17/2016
JOB DESCRIPTIONAPPLY 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.
The Clinical Development Group collaborates closely and maintains excellent working relationships with various internal groups, including Preclinical Science, Regulatory Affairs, Business Development, and New Product Planning. 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 work flexibly and collaboratively together in a matrix environment, with a high degree of personal accountability for the success of novel and aggressive clinical programs and timelines. We have ongoing and planned clinical programs in Phases I-IV, primarily in psychiatry.
We are currently seeking a highly motivated physician to join our Clinical Science Department as a Medical Director at the Associate Director level. This physicians primary responsibility will be to advance the companys programs in psychiatry. In addition, this physician will help advance early stage compounds into the clinic. This position will report to a senior physician within the Clinical Development group, and will play a critical role in the medical and scientific management of programs.
Key responsibilities for the Associate Medical Director include:
* Conduct ongoing medical monitoring of clinical trials
* Assist with the strategic planning and execution (including study design, method selection, etc.) of Phase I through IV global clinical trials
* Analyze and interpret data expertly, and clearly communicate results both internally and externally
* Contribute to and review clinical documents (slide presentations, protocols, clinical study reports, regulatory submission sections, investigators brochures, etc.)
* Work collaboratively with other Medical Directors, and colleagues in Biostatistics, Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs
* Work closely with Contract Research Organizations, Principal Investigators, key opinion leaders, and US and EU regulators
Minimum Education & Experience Requirements:
* MD -- additional pharmaceutical drug development experience and/or academic research experience is a plus.
* Expertise in psychiatric disorders
* Excellent verbal, interpersonal and written communication skills, a strong scientific background, creativity, flexibility.
* Experience in clinical trial design.
* Ability to work in a team environment with both internal and external (CRO) members.
* Familiarity with thought leaders in the field of psychiatry, particularly schizophrenia.
* Domestic and international travel (approximately 20%) is required.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.