AbbVie’s Development Biological Sciences (DBS) department is seeking a Director-level professional to provide oversight of China-based CRO nonclinical toxicology studies and to support nonclinical development programs and regulatory submissions in China. This position will report to Head of Development Sciences, China, and will maintain a strong connection with the DBS Portfolio Leadership Group and the Toxicology Operations Group in Lake County, Illinois.

The primary responsibility of this role is to serve as the liaison between AbbVie and the China-based CRO, ensuring the effective initiation, conduct, and completion of nonclinical toxicology studies performed in China. This position will maintain ongoing communication with the appropriate AbbVie US stakeholders throughout the study lifecycle.

In addition, this role will support development programs and regulatory submissions by preparing appropriate documentation, including briefing books, CTDs, and responses to CDE inquiries, and by providing regulatory guidance for intended interactions. The position will work closely with the US-based DBS development representative and/or study monitor to ensure alignment and consistency across all program activities.

The ideal candidate will have 10 or more years of experience in nonclinical safety within the pharmaceutical industry. The successful candidate should demonstrate experience and capability in advancing drug candidates from discovery through marketing, with specific knowledge of Chinese regulatory requirements. The candidate should also have relevant nonclinical toxicology study director or study monitor experience both from a non-GLP and GLP perspective. This position is expected to have significant impact by contributing scientific expertise in nonclinical safety assessment, knowledge of industry best practices, and understanding of relevant regulatory guidelines in China as well as other regulatory regions (e.g. US, Europe).

This position is located in China, with travel to China-based CROs and regulatory sites as required.

Essential Responsibilities:

• Strong knowledge of CDE regulatory guidance and processes related to the development and commercialization of new drug entities.
• Prepare nonclinical documents to support clinical studies and regulatory submissions in China.
• Respond to inquiries from the CDE and clinical sites, as needed, to support ongoing clinical trials.
• Study monitoring of nonclinical toxicology studies for CRO based studies conducted in China.
• Effectively articulate and communicate nonclinical safety needs from a China perspective across multiple drug modalities, including but not limited to small molecules, biologics, ADCs, and cell and gene therapies, and across therapeutic areas including but not limited to oncology, neuroscience, and immunology.
• Author and submit regulatory documents, including IBs, INDs/CTAs, NDAs/BLAs, and regulatory responses, and interact with China regulatory agencies as needed.
• Conduct China test facility inspections, as needed, to ensure study quality and performance.
• Manage relationships with vendors and key collaborators.
• Demonstrate the ability to rapidly resolve issues or conflicts associated with study conduct.