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Director, Clinical Research (Ph.D) - Neuroscience

The Director, Clinical Research will design and oversee the conduct of clinical programs/studies for Phase II and III development of compounds targeting neurological disorders encompassing epilepsy and other studies. The Director will provide input into clinical development strategies for these indications and potentially, others.
Responsibilities include but are not limited to:
1. Directing and implementing Clinical research plans and programs according to established design principles. Directing the integration of the CDP and DDP
2. Leading the development of Clinical Protocols to meet CDP objectives
3. Serving as a Study Director and driving the execution of studies from protocol concept to final report including interpretation of clinical data
4. Serves as Study Director for a study or clinical program; including review of study safety data and implementing strategies to identify, monitor and resolve clinical program/ trial issues. Leading the Clinical Subteam.
5. Serving as a SME to provide direction to all project team functions, Organizing Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOLs regarding program strategy and scientific advice
6. Interpreting study data and developing integrated summaries of safety and efficacy
7. Contributing clinical expertise to regulatory documents (e.g., briefing books, INDs, NDAs, etc.). May represent Clinical in discussions with Health Authorities
8. Acting as a coach and mentor to staff members across the NBG unit
9. Setting key deadlines and project milestones for projects within the function Job Qualifications € Ph.D required, ideally in Neurology or Psychiatry
A minimum of 7-10 years in pharmaceutical clinical development with experience directing Neurology Phase II-III global multicenter studies
Strong interpersonal and leadership skills; demonstrated ability to build consensus and drive change in a matrix environment with cross functional teams
A thorough understanding of clinical research methodology including study design, protocol writing, and study report preparation
Comprehensive understanding of GCP of local regulatory requirements
Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience
Working knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action
Knowledge of scientific and clinical research techniques in the neurology area
Previous participation in the selection of new compounds for clinical development and IND filing in neuroscience through technical evaluation of licensing and/or partnering opportunities.
Solid understanding of the drug development process based on experience gained in the pharmaceutical or biotech industry
Excellent oral and written communication and presentation skills
Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects preferred
Experience with pediatric and epilepsy studies is a plus
Annual travel required may be up to 10% (domestic and some international) Auto req ID 3949BR Job Type Full-time
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