Senior Scientific Director, Neuroscience

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.  Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports.  May recruit clinical investigators and negotiates study design.  Responsible for creating clinical development plans and for directing human clinical trials, phases I – IV for company products under development.  Expertise/experience in Neuroscience preferred.

Responsibilities:

• Responsibilities also include adverse event reporting and safety responsibilities monitoring. 
• Coordinates and develops reporting information for reports submitted to Global Regulatory Authorities, including EMEA, FDA, and other national authorities. 
• Monitors adherence to protocols and determines study completion.  May act as consultant/liaison with other corporations when working under licensing agreements.
• Accountable for the design and management of clinical development plans based on strong medical and scientific principals, knowledge of the regulatory requirements and AbbVie’s customers, markets, business operations and emerging issues.
• Responsibility may extend from early translational development activities to mature product life cycle management strategies.
• Manages the design, conduct and reporting of clinical trials in line with the development, regulatory and commercial strategy.
• May supervise 2-10 employees either directly or in a matrixed environment
• Should be able to serve as a global product safety offices, responsible for global product safety.
• Participation in design and execution of clinical trial safety, product safety and risk management plans. 
• Responsible for routine and ad-hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies. Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
• May be responsible for opinion leader development within one or more therapeutic area(s).
• May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
• Oversee scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information.
• Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
• Act as the scientific leader for several clinical programs within an area.
• May represent the medical function to the GPT for clinical development activities.
• With project director, responsible for setting clinical trial strategy to carry out overall program objectives
• With project director, ensures budgets, timelines, compliance requirements are factored into programs' scientific activities
• Works independently.
• Can address complex problems within discipline or across several projects
• Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.
• Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors

Requirements:

PhD with relevant therapeutic specialty in an academic or hospital environment. 

Completion of fellowship is preferred.

Minimum of 5 years of clinical trial experience in the pharmaceutical industry or academia or equivalent.  7+ years of experience is preferred.

Proven leadership skills in a cross-functional global team environment. 

Ability to interact externally and internally to support global business strategy. 

Ability to run a complex clinical program independently.

Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. 

This knowledge set is typically associated with a minimum of 7 years of clinical development experience in a pharmaceutical company/CRO/Bio Technology company plus expert knowledge in a relevant therapeutic specialty. 

Must have an understanding of Pharmacovigilance practices for Clinical Development programs.   Ability to interact externally and internally to support global business strategies. 

Must possess excellent oral and written English communication skills. Must have an in-depth understanding of the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements.