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.
Job responsibilities include but are not limited to:
- Directing and implementing Clinical research plans and programs according to established design principles. Directing the integration of the CDP and DDP
- Leading the development of Clinical Protocols to meet CDP objectives
- Serving as a Study Director and driving the execution of studies from protocol concept to final report including interpretation of clinical data
- 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.
- 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
- Interpreting study data and developing integrated summaries of safety and efficacy
- Contributing clinical expertise to regulatory documents (e.g., briefing books, INDs, NDAs, etc.). May represent Clinical in discussions with Health Authorities
- Acting as a coach and mentor to staff members across the NBG unit
- Setting key deadlines and project milestones for projects within the function
- Ph.D required, ideally in Neurology or Psychiatry
- A minimum of 5 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)
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.