Website Silicon Therapeutics
Silicon Therapeutics is an integrated computational drug discovery company focused on developing novel medicines for diseases with targets that are currently considered to be challenging for traditional approaches. Our platform closely represents the real dynamical nature of targets using accurate all-atom simulations, enabling us to design and optimize compounds for targets that were previously considered “undruggable.” Our science, our team, and our mission are focused on applying advanced computational technologies to build and progress a pipeline of innovative medicines for patients. Silicon Therapeutics is headquartered in Boston, MA, USA with offices in Shanghai, China. Learn more at www.silicontx.com
We are seeking an associate director, or a principal investigator with extensive experience supporting DMPK and nonclinical pharmacology in small molecule drug discovery and development. A successful candidate will provide scientific leadership and play a key role providing nonclinical expertise in support of drug candidate nomination from late-stage research, regulatory submissions through early clinical stages. The individual will lead DMPK and pharmacology function at Silicon Therapeutics (i.e. ADMET profiling, animal model & dose selection).Significant experience in PK/PD assessment and predicting human exposure is a must have. In addition, experience in formulation or non-clinical toxicology will be a plus.
The individual will work collaboratively with internal and external multi-functional teams, collaborators and consultants to advance the drug candidate through IND enabling studies. The individual will be responsible for the planning, implementation and organization of nonclinical studies along with the use of drug exposure to bridge across species, presentation of data to project teams, cross-functional sub-teams, and external consultants/collaborators.
- Contribute to an overall drug development strategy to support nonclinical and clinical pharmacology development.
- Represent and lead the DMPK/Pharmacology functions in project teams; Design and guide externally conducted PK, efficacy, TK, ADME studies at CROs, present and interpret data to project team and senior management.
- Define PK/PD relationships, model dose response and dose schedulesto project efficacious dose and exposure range as well as dose and exposure multiplesin humans.
- Select non-clinical species based on in vitro/in vivo data and provide justification.
- Contribute to regulatory submissions (IND/CTDs, etc.) of preclinical PK/TK summaries and other regulatory activities.
WHO YOU ARE
- Ph. D. or equivalent with 8+ years’ experience in DMPK, pharmacology or toxicology in a pharmaceutical/biotech, or a reputable CRO setting, with > 3 years of experience serving as project rep on DMPK and/or pharmacology.
- Experience in nonclinical development of small molecules from discovery through development with a track record of multiple INDs.
- Extensive experience in designing in vivo studies, interpreting data, generating regulatory documents.
- Good understanding of both theoretical pharmacokinetics theory and practical applications.
- Experience with PK software and have an understanding of non-compartment & multi-compartment modeling.
- Experience in animal PK/TK studies, including protocol design & study conduct.