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 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 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.
- 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.
- 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.
- Ability to anticipate, recognize and resolve scientific and technical problems that are encountered during various phases of drug development
- Strong communication and presentation skills
- Ability to work in collaboration with other functional areas and within a matrix organization.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.