Associate Director, Toxicology
北京, 北京, 中国
工作概览
Brii Biosciences is seeking a highly motivated and experienced Associate Director or Director of Toxicology to join our dynamic R&D team. This role serves as the toxicology subject matter expert across Brii’s portfolio, supporting programs from early discovery through clinical development and regulatory submission. The ideal candidate will bring deep expertise in nonclinical development strategies for small molecules, RNA-based, protein therapeutics including therapeutic vaccines, and demonstrate adaptability to emerging therapeutic modalities. The optimal candidate will have a solid understanding of requirements and subtleties of working across several regulatory agencies including the US, EU and China.
工作职责
- Design and oversee toxicology strategies as well as execute studies to enable research and development programs.
- Critically reviews and interprets nonclinical toxicology study reports and coordinates report finalization. Ensures documentation is consistent with the necessary global regulatory and compliance requirements.
- Characterize the toxicology profiles of candidate molecules and contribute to investigative studies and first-in-human dose selection strategies
- Manage external collaborations with CROs/CDMOs to ensure high-quality study execution and adherence to program timelines.
- Present toxicology-related data to internal project teams and senior leadership to support decision making
- Contribute to the preparation and review of regulatory submissions (e.g., CTAs, INDs, BLAs), and engage with regulatory authorities as needed.
- Collaborate with discovery teams to transition candidates into development.
- Collaborate with program teams and engage in non-toxicology projects, including preclinical (in vitro/in vivo pharmacology studies) and clinical activities (e.g., target selection reviews, disease area assessments CRO engagement, assay review).
- Stay current with scientific literature, methodologies, and developments relevant to Brii’s pipeline and R&D initiatives.
- Conduct literature reviews to evaluate new targets or therapeutic modalities and provide critical assessment outcomes to program teams and senior leadership.
任职资格
- Ph.D., DVM, or equivalent in toxicology, pharmacology, or a related field.
- Minimum of 7 years of industry experience in pharmaceutical or biologics R&D, preferably with a focus on RNA-based therapeutics.
- Proven expertise in preclinical drug development and regulatory documentation include authoring and reviewing relevant sections of regulatory submissions, and preparing science-based responses to regulatory inquiries. IND experience is required, BLA or NDA experience desired.
- Strong knowledge of GLP regulations and global regulatory guidelines related to toxicology and nonclinical development.
- Deep understanding of QA, regulatory, and clinical functions to guide nonclinical strategy across all stages of development.
- Strong written and verbal communications skills, with the ability to clearly convey complex scientific information.
- Demonstrated ability to work effectively in cross-functional, matrix team environments.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Brii Biosciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. We value diversity and are committed to creating an inclusive environment for team members from all backgrounds.