Description:

AbbVie’s Development Biological Sciences department is seeking a Senior Director for its Portfolio Leadership Group. This pivotal leadership role will serve as a nonclinical safety representative for assigned molecules across AbbVie’s diverse portfolio. As a safety representative, the Senior Director will be responsible for the overall strategy and execution of the nonclinical toxicology program, collaborating cross-functionally with project leads, providing data interpretation at various internal and external venues, and authoring regulatory documents. 

The ideal candidate will have 15+ years of experience in the area of non-clinical safety within the pharmaceutical industry. He/she should have the experience and ability to develop drug candidates from discovery through marketing. This senior-level position is expected to have a high impact contributing scientific expertise in nonclinical safety assessment, knowledge of industry best practices and pertinent regulatory guidelines, and a vision of future enhancements in the field.

Responsibilities

• Drive the strategic vision and direction for nonclinical safety, influencing key R&D and portfolio decisions at the organizational level.

• Serve as an active member for multi-disciplinary project teams as a nonclinical safety functional area subject matter expert.
• Articulate and communicate non-clinical safety strategies and provide development plans for multiple drug modalities including but not limited to small molecules, biologics, ADCs, and/or cell and gene therapies, across various therapeutic areas including but not limited to oncology, neuroscience, and immunology.
• Participate in due diligence reviews of drug products 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.
• Generate impurity, excipient and metabolite risk assessments as necessary during the life cycle of a drug candidate.
• Lead, mentor and develop others as it pertains to drug development and the execution of the portfolio, with an emphasis on the nonclinical aspects.
• Participation in pharmaceutical industry consortia related to nonclinical aspects of drug development.