DMPK and Clinical Pharmacology Group within Early Development and Pharmacology, is searching for a Principal Scientist to present DMPK group on interdisciplinary project teams. The successful candidate will provide PK/PD/ADME expertise on autoimmune diseases discovery and development project teams. Experience with ADME and DMPK experimental design, implementation, data interpretation, as well as modeling strategies and tactics to advance high-quality small molecules is essential. The candidate should have a strong understanding of DMPK and PK/PD areas applicable to animal models and translation into humans and will lead the DMPK function for discovery projects from early target validation stages, into the nomination of the development candidate, and through support of clinical studies.
- Design, plan, prioritize and conduct experiments through CROs or inhouse for in vitro/in vivo ADME studies of drug candidates in laboratory animals and humans using radiolabeled and non-labeled drugs in support of Discovery and Development.
- Analyze the in vitro data, provide DDI risk assessment , and issue management, including DDI related exclusion criteria for clinical trials.
- Develop and implement innovative, quantitative analyses and strategies for translational modeling across Discovery and Development projects
- In a matrix manner, lead the translational modeling approaches and best practices, ensuring that translational modeling strategies and technologies are aligned with project and functional deliverables
- As part of A DMPK group liaise with Discovery biology, pharmacology, toxicology, and clinical scientists to collect data , generate In vitro-In vivo correlation, and transfer the knowledge through translational models into clinical design.
- Establish and maintain effective collaborations with key senior stakeholders within Early Development and Pharmacology, Research and Clinical to facilitate knowledge and data integration for target prioritization, biomarker selection, candidate selection, guidance in (pre)clinical study design, human dose prediction and calculation of therapeutic index
- Write/review preclinical and clinical ADME sections for Common Technical Document (CTD) to support regulatory (IND/IB/NDA) filings and provide response to regulatory queries related to DMPK/DDI.
- Effectively communicate and influence on strategies related to DMPK and translational modeling and simulation.
- Prior experience as a DMPK project team representative and work in an experimental in vitro and in vivo ADME field is must
- A strong understanding of PK and ADME concepts, and practical experience in in vitro and in vivo extrapolation in at least one of the following areas: absorption, distribution, enzyme metabolism, transporter, and excretion is essential.
- Hands-on experience with relevant modeling software and programming languages including, R,/S-plus, SAS, NONMEM, NMLE, WinNonLin/Phoenix, etc. is required
- Must have a strong understanding of Translational Sciences, ADME, PK/PD modeling and human dose prediction in one or more therapeutic areas and be able to give clear recommendations for the design of preclinical and clinical studies
- Understanding of small molecule drug development (including novel modalities) and relevant analytical methods for measuring drug and biomarkers in preclinical and clinical study samples is highly desired
- Publication record demonstrating In vitro ADME, IVIVC, PK/PD modeling examples is highly desired
- Familiar with conducting pre-clinical TK and Toxicology studies is plus
- Must have strong communication skills and the ability to influence, negotiate and communicate with both internal and external stakeholders, and to audiences of diverse backgrounds
- Highly motivated, self-driven and results-oriented person with excellent communication and presentation skills, capable of both leading and being led
- High degree of flexibility in adapting to different projects and personalities as well as excellent networking and relationship-building skills (both internal and external) required.
- Track record of contribution to regulatory documents (e.g. IND, IB, PIP) and attend meetings with regulators as required.
- Hands-on experience with PBPK model development and implementation is a plus
- Passion for data analysis, solving technical problems and applying new technologies to further scientific goals and answer key scientific questions enabling informed decision-making
- Doctorate (Ph.D.) in chemical, or biomedical engineering; applied mathematics; quantitative pharmaceutical sciences or a related field, with at least 7 years of pharmaceutical industry experience.