The Director, Neurology Global Clinical Development - Alzheimer's Disease & Brain Health is intended for a dynamic individual with clinical leadership experience in the pharmaceutical industry. This role will provide the organization with a qualified individual to design and oversee the conduct of clinical studies for late phase development of a compound for Early Alzheimer's Disease. Additionally, this individual will contribute to the organization by analyzing and communicating results for these studies and by providing input into clinical development strategies as well as by potentially performing medical monitoring for these and, possibly, other studies within the Business Group.
- Assisting the project team clinical lead in planning, implementation, managing and reporting of CDPs and programs.
- Developing Clinical Protocols to meet the objectives of the CDP.
- Serving as a Study Director for selected trials and delivering final protocol, implementation strategy and clinical data review plans.
- Depending on credentials, the hired candidate may serve as a medical monitor and provide input into clinical issues, adverse events, laboratory data, patient inclusion/exclusion criteria.
- Identifying, monitoring, and resolving clinical program/trial issues, and reporting progress to management.
- Serving as the SME to provide input to project teams across functions, presenting at Advisory Board meetings, and liaising with KOLs regarding protocol study strategy and issues.
- Interpreting study data and developing integrated summaries of safety and efficacy.
- MD/PhD; MD candidates with 3+ years of industry clinical research experience in Neuroscience, preferably Dementia and/or Alzheimer's Disease or PhD candidates with 5+ years in clinical research in the pharmaceutical industry, preferably with experience in Neuroscience focused on Dementia and/or
- A thorough understanding of clinical research methodology including study design, protocol writing, CRF preparation, and Clinical Study Report preparation
- Experience directing late stage development studies; Regulatory filing experience a plus
- Working knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action.
- Knowledge of GCP and local regulatory requirements. o Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industrial experience.
- Knowledge of medical, scientific, and clinical research techniques in the neurology/psychiatry therapeutic area.
- Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects and proof-of-pharmacology