Director, Preclinical Safety

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose:

Serves as a safety pharmacology strategist for assets across AbbVie’s portfolio. Responsible for the overall strategy and execution of the safety pharmacology strategy, collaborating cross-functionally with project leads, communicating decision-enabling data interpretation at various internal and external venues including Senior Leadership at governance meetings, and authoring regulatory documents. 

This senior-level position is expected to have a high impact contributing scientific expertise in safety pharmacology assessment, knowledge of industry best practices and pertinent regulatory guidelines, and a vision of future enhancements in the field.  The candidate will also manage a group of internal safety pharmacologist and staff.

Responsibilities:

• Serve as an active member for multi-disciplinary project teams as a safety pharmacology functional area expert. Manages several programs of very high complexity. Influences project timelines to ensure proper completion of required activities.
• Articulate and communicate safety pharmacology strategies and provide development plans for multiple drug modalities including but not limited to small molecules, peptides, biologics, and ADCs, across various therapeutic areas including, but not limited to, oncology, neuroscience, and immunology.
• Contribute to due diligence reviews by conducting technical assessments of external assets to identify potential risks and provide recommendations for partnership or in-licensing.
• Author and submit regulatory documents (IBs, INDs/CTAs, NDAs/BLAs, regulatory queries) and interact with regulatory agencies (US and ex-US) as needed.
• May participate in pharma