Scientific Director / Sr. Director, Toxicology Development Biological Sciences (nonclinical)

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

AbbVie’s Development Biological Sciences department is seeking a Scientific Director for its Portfolio Leadership Group. The primary function of this role will be to serve as a nonclinical safety representative for assigned molecules across AbbVie’s diverse portfolio. As a safety representative, the Scientific 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 10+ years of experience in the area of nonclinical 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.

This position is located at our headquarters in Lake County, IL, just north of Chicago and will be expected on-site, minimally, 3 days a week.

Essential Responsibilities:

• 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.
• Support and mentor 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

 

Qualifications

*This position can be hired at Scientific Director or Sr. Director level dependent upon years of relevant experience and education*

Qualifications for the Scientific Director level:

• PhD or DVM required
• 10+ years of relevant experience in pharmaceutical industry leading nonclinical safety programs
• Experience authoring relevant regulatory documents and responding to requests from regulatory agencies
• Deep expertise in a particular therapeutic area or modality (e.g. gene therapy) is a benefit, but not required
• General awareness and understanding of drug metabolism and pharmacokinetics and its interplay with safety (e.g. MIST, drug-drug interactions, toxicokinetics, anti-drug antibodies...) is a plus.
• Skilled in project/program management and leadership
• General computer skills and knowledge of the Microsoft applications including but not limited to Microsoft Word, Excel, and PowerPoint

Qualifications for the Sr. Director level:

• Doctor of Veterinary Medicine (DVM), Doctor of Medicine (DM), or PhD in a relevant area, preferably with a certification in the assigned therapeutic area.
•  At least 8 years’ experience of major drug development experience gained within the pharmaceutical industry or at least 12 years’ experience in science or business-related field and demonstrated scientific expertise.
•  A solid knowledge of all aspects of the complete pharmaceutical research and development process.
• Broad international experience, specifically regarding drug development and associated compliance and filing requirements.
• Proven experience of managing a large group of scientists and technicians in multiple locations, supporting global drug development projects.

Leadership Attributes:

• Ability to anticipate, recognize and resolve scie