Overview of Clinical Development
The Clinical Research group at Alkermes is located in Waltham, MA. Functions include Clinical Science and Translational Medicine (including Clinical Pharmacology). The group is tasked with designing and conducting clinical trials (Phases I-IV; domestic and international) aligned with corporate strategy and with 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 Research 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.
We are currently seeking a highly motivated, experienced pharmaceutical industry physician to join our Clinical Research Department as a Senior Medical Director. This physician’s primary responsibility will be to advance the company’s programs in schizophrenia and depression. In addition, this physician will help advance early stage compounds into the clinic.
Key responsibilities for the Senior Medical Director include:
- Accountability for 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.
- Ongoing medical monitoring of clinical trials.
- Contributing to, reviewing, and approving clinical regulatory documents (clinical study reports, regulatory submission sections, investigator’s brochures, etc.)
- Working collaboratively with Medical Directors, Biostatistics and Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs.
- Working with US and EU regulators.
- Mentoring junior team members, and providing guidance and opportunity for their professional development.
Minimum Education & Experience Requirements:
- MD with at least five to seven years of pharmaceutical drug development experience.
- Expertise in Psychiatry, particularly treatment of schizophrenia and depression is preferrred.
- Direct experience interacting with regulatory authorities.
- Excellent verbal and written communication skills, a strong scientific background with industry drug development experience, and strong team leadership skills are required.
- Ability to work in a team environment with both internal and external (CRO) members.
- Experience in Clinical trial design specific to schizophrenia and/or depression.
- Familiarity with thought leaders in the field of treatment of schizophrenia and/or depression.
- Experience in design of proof of concept studies.
- Domestic and international travel (approximately 25%) is required.