Senior Scientific Director, Head of Translational Neuroscience (Glenview)
Employment Type: Full-Time
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Clinical Development oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities of one or more clinical development programs in the Neuroscience TA. You will lead the development, validation and deployment of novel scientific methods for clinical trials in collaboration with internal and external experts and stakeholders through the entire product lifecycle. Responsibilities: Transitional Science Lead
Global Clinical Development
- Responsible for leading a group of translational scientists focused on the identification, development, validation and deployment of neurological biomarkers through partnerships with internal Discovery capabilities, BD and external relationships.
- Responsible for leading the development, implementation and curation of a digital biomarker strategy for the CNS therapeutic area in collaboration with internal and external stakeholders
- May supervise 2-10 employees either directly or in a matrixed environment.
- Provides subject matter expertise for clinical programs within the CNS TA.
- Consults or liaises with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
- Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
- Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
- Accountable for continuous improvements in the quality and innovation of clinical development plans based on strong scientific principles, knowledge of the regulatory requirements and AbbVie's customers, markets, business operations and emerging issues.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a subject matter expert for key regulatory discussions or interactions
- Contributes to the scientific education of investigators, clinical monitors, and Asset Team members related to therapeutic area or disease specific information.
- Participates in the design and execution of clinical trial safety, product safety and risk management plans.
- Coordinates and develops reporting information for reports submitted to Global Regulatory Authorities, including EMEA, FDA, and other national authorities.
- Aligns with the Asset Leader on the clinical trial strategy to carry out overall program objectives
- Aligns with the Asset Leader on budgets, timelines, compliance requirements are factored into programs' scientific activities
- Able to address complex problems within a discipline or across several projects all with inherent risks and ambiguities
- Exercises prudent judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.
- Enjoys working on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors
- Works independently.
- MD or PhD with relevant Neuroscience therapeutic specialty in an academic, clinical or research environment.
- Completion of post-doctoral fellowship is preferred.
- Minimum of 5 years of translational or early stage drug development experience in the pharmaceutical or biotech industry or equivalent. 7+ years of experience is preferred.
- Proven leadership skills in global, cross-functional global team environments.
- Ability to interact externally and internally to support global business strategy.
- Ability to run a complex clinical program independently.
- Recognized expertise of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols across all phases of development
- A minimum of 5-7 years of early/translational clinical development experience in a pharmaceutical company, CRO or bio-technology company plus expert knowledge in a relevant Neurosciences therapeutic specialty.
- Demonstrated ability to interact externally and internally to support global business strategies.
- Must possess excellent oral and written English communication skills.
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