Medical Director, Clinical Development (Neuroscience)

Job Responsibilities

• Provide cross functional Clinical Development leadership for internal and external team members in the delivery of clinical studies
• Provide a role in the strategic planning of clinical studies and programs, including the development of study design, milestones, key deliverables
• Provide support and oversight to all other functional areas of the study teams throughout the lifecycle of the study (startup, maintenance, closeout) to ensure data integrity, resolve and/or escalate issues, achieve alignment, and adhere to study goals and timelines
• Act as primary contact for medical communication to ensure medical safety within studies
• Develop and maintain relationships with sites and Investigators
• Provide medical monitoring, including reviewing study participant eligibility, protocol interpretation, coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management
• Work with Biometrics to contribute to the analysis and interpretation of clinical results
• Author, review, and/or provide strategic input into clinical sections of regulatory documents including IND submissions, annual updates, DSUR, investigator brochures, and briefing documents
• Author, review, and/or provide strategic input into study specific documents such as study protocols/amendments, informed consent documents, case report forms, placebo justifications, and clinical study reports
• Author, review, and/or provide strategic input into scientific publications, manuscripts, posters, or other documents intended for external audiences
• Represent Clinical Development at Regulatory Authority Meetings
• Present the clinical development aspects of a project and clinical trial results at internal or external meetings
• Communicate to Senior Management and relevant functions any potential issues, risks or changes to the Clinical Development Plan
• Complete all company and job-related training as assigned within the required timelines

Job Requirements

• MD degree or international equivalent; active medical license preferred
• Specialty training or board certification in Neurology or Psychiatry preferred
• Minimum 3 years clinical/research experience in the pharmaceutical industry, relevant governmental organizations, or academic research setting required
• Ability to travel at least 30%
• Ability to work in a team setting as well as function as an individual contributor
• Ability to work efficiently and under tight timelines
• Ability to communicate effectively
• Ability to be flexible in an ever-changing environment
• Ability to think strategically and be able to anticipate problems before they occur
• Ability to be proactive in finding solutions to issues
• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• Must be able to perform all essential functions of the position, with or without reasonable accommodation