Director, DMPK/preclinical
上海, 上海, 中国
工作概览
This leadership role will collaborate closely with multiple R&D functional areas to support DMPK needs for both clinical and preclinical programs, enabling decision making for advancement of both drug discovery and development projects. The candidate will lead the DMPK group and provide scientific leadership in study design, data interpretation and study execution and reporting. Prior experiences with preparation and review of regulatory filing documents to support IB, FIH and CTA filings is required. Broad experiences with small molecules, oligonucleotides and protein therapeutics is preferred.
工作职责
- Support discovery and development project teams across diverse therapeutic areas that containing small molecule, oligonucleotides and protein therapeutics, contribute to the project strategies and provide recommendations for key in vitro and in vivo ADME/PK studies.
- As the DMPK leader, design strategies for DMPK, bioanalysis, PK/PD and clinical pharmacology studies and outline internal experimental protocols and approaches to address key ADME and PK properties for both discovery and development projects.
- Assume strong scientific and strategic lead role, effectively engage internal key stake holders across multiple R&D functional areas and external experts to work collectively to enable advancement of the internal programs.
- Leading regulatory related activities in DMPK areas for R&D and generating and reviewing regulatory documents such as IBs, INDs & CTAs, and providing scientific support on all licensing activities.
- Design and conduct metabolite identification and other hypothesis-driven in vitro and in vivo drug metabolism studies to aid in lead optimization, candidate selection, and clinical development of NCEs for novel drug targets.
- Manage collaborations with CRO/CMO for outsourcing activities and Ensure reporting timelines for all DMPK related reports.
任职资格
- PhD degree with a 10+ years of experience in a DMPK and/or clinical pharmacology or related field
- Extensive knowledge of preclinical drug development and regulatory filing documents, including preparation and review of regulatory documents to support IB, FIH, CTA filings is required.
- Excellent knowledge of DMPK, PK/PD and TK in drug development & discovery, broad experience with small molecules, oligonucleotides and protein therapeutics
- Demonstrated ability to conduct innovative research in DMPK applied to the discovery of novel drug candidates to achieve defined milestones in a fast-paced environment
- Extensive knowledge in developing in vitro and in vivo methods to build ADME and DDI profiles.
- Experienced in bioanalytical method development and application in analytical chemistry tools for drug discovery and development
- Strong written, verbal, and interpersonal communications skills including ability to communicate scientific information clearly and effectively; Fluent in English and Chinese
- Demonstrated ability to work effectively with cross-functional groups in a matrix team environment.
- Demonstrated experiences in mentoring and/or managing direct reports.
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.