Medical Director, Clinical Development, Neurology

Key Responsibilities

• Support to the VP of Clinical Development, Neurology in a variety of projects and responsibilities
• Generate study protocols/amendments, design and execute clinical study programs, and review and interpret study results
• Facilitate Clinical Development goals and achievement of study quality metrics
• Interface with various functions, including Regulatory, Clinical Operations, Drug Safety, Medical Affairs, and Legal
• Track (in- or outsourced) study programs, collaborating with Clinical Operations, Drug Safety and vendors; activities include site selection, collection and analysis of clinical data, reporting and providing ongoing medical monitoring for clinical trials
• Stay up to date on current information regarding regulations and guidelines for the therapeutic area and scientific advances in the relevant field
• Provide medical oversight of the implementation of clinical trials
• Maintain a working knowledge of projects in his/her functional area
• Provide therapeutic and protocol-specific scientific training to project teams and new hires
• Assist with (internal) legal inquiries on the science related to our products
• Participate in the design and review of study-related documents and professional abstracts and manuscripts
• Maintain a high level of expertise engaging key opinion leaders and investigators through impactful participation in internal meetings and attendance at professional seminars, advisory boards, workshops and educational programs
• Assist with the preparation and/or review of data listings, summary tables, study results, study reports, and clinical/regulatory/safety documents (e.g., investigator brochures)
• Assists with strategic planning and prepares clinical development plans
• Assists with business development due diligence activities
• Assists with authoring and/or reviewing relevant Pre-IND, IND, and BLA sections and generating responses to information queries
• Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice

Qualifications

• MD, or MD with a PhD with post-graduate training and experience. Neurologist preferred but other relevant medical specialties (e.g. Psychiatry) can be considered with significant neuroscience/multiple sclerosis clinical trial experience
• Clinical or research experience in this field of specialization is highly desirable. Minimum of 3 years of clinical trial/research experience in an industry setting; Phase 3 clinical development and execution experience is strongly preferred
• Hard working, driven to achieve sound results
• Experience in pharma-related clinical research and patient care or investigational site experience desirable
• Experience in analysis and interpretation of clinical data (safety and efficacy)
• Demonstrable experience in writing or editing reports of scientific research, either for regulatory submission or for scientific publications
• Able to work in a fast paced, cross-functional, team-oriented professional environment
• Experience working with personnel with varied professional (technical and educational) backgrounds
• Willingness to travel 10-15% of the time, including travel to key medical conferences and study-related events such as investigator meetings