Pre-Clinical Project Manager
上海, 上海, 中国
工作概览
Brii Biosciences is seeking a highly motivated and experienced preclinical project manager to join our dynamic R&D team. In this role, the individual will provide hands on operational and project management leadership for preclinical development programs from lead candidate selection through IND enabling studies. The preclinical project manager will partner closely with Biology, Pharmacology, DMPK, Bioanalysis, Toxicology, CMC, Regulatory, Program Management and external CROs to ensure critical preclinical studies are planned and executed efficiently within the budget and aligned with program strategy and regulatory expectations to support key development milestones.
工作职责
- Support functional leads in developing and maintaining integrated preclinical study plans spanning pharmacology, DMPK, bioanalysis, and toxicology, ensuring operational feasibility and alignment with technical requirements
- Coordinate timelines and interdependencies for preclinical studies supporting candidate selection and clinical enablement
- Drive study execution toward key milestones and provide accurate updates to the program PM for inclusion into the integrated program plans
- Facilitate preclinical team and working session meetings including scheduling, action-item tracking, and follow-through on operational decisions
- Manage preclinical outsourcing activities, including CRO identification, scope definition, contracting support, study start-up, and execution tracking, and issue escalation
- Ensure operational readiness and compliance for preclinical studies by coordinating reviews of protocols, monitoring study conduct, and organizing QC of draft/final reports to meet internal standards and GLP/non-GLP requirements
- Oversee logistics for preclinical materials, samples, and data flows to ensure timely bioanalysis, data processing, and reporting across multiple CROs and internal functions
- Identify and proactively manage preclinical operational risks (e.g., assay readiness, vendor capacity limitations, sample logistics challenges)
- Develop contingency plans for preclinical study execution including reprioritization, timeline adjustments, and scenario planning across parallel programs
- Escalate preclinical execution risks clearly and early, with clear recommended solutions
- Serve as the central operational point of coordination between scientific leads and development program leads
- Prepare quality preclinical-specific materials and operational summaries that feed into program-level governance reviews, milestones and decision-making meetings
任职资格
- BS or MS in life sciences (PhD preferred but not required), 5+ years of experience in preclinical operations, project management, or preclinical program management in biotech/pharma or CRO environments
- Hands on experience supporting preclinical pharmacology, DMPK, bioanalysis, and GLP toxicology studies
- Strong experience managing CROs and external vendors in preclinical and early development settings
- Solid understanding of IND driven preclinical workflows and timelines
- Demonstrated ability to operate effectively in fast moving, cross-functional, matrixed team environments
- Good understanding of QA, regulatory, and clinical functions to guide nonclinical strategy across all stages of development.
- Experience with oligonucleotide therapeutics (siRNA, ASO, or related modalities) preferred
- PMP or equivalent project management training (a plus)
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.