Senior Scientist, Pharmacokinetics
Pliant Therapeutics is a public, clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic disease. The Company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The Company’s lead product candidate, PLN-74809, is an oral, small molecule selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), and are currently in Phase 2a clinical trials for these indications. Pliant’s second product candidate, PLN-1474, is an oral, small molecule selective inhibitor of the αvβ1 integrin, in development as a potential treatment forlate-stage liver fibrosis under a partnership with Novartis. The Company also has discovery and development programs in oncology and muscular dystrophies. The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.
We are seeking a highly motivated and experienced Senior/Principal Scientist PK/PD who is driven to understand the pharmacokinetics (PK) and pharmacodynamics (PD) of novel drug candidates.
The main focus will be evaluating the translational projection and PKPD-modelling of novel small molecules and therapeutic proteins. This broad role includes the development of PKPD models and the translation follow development candidates through IND-enabling studies and early clinical development. This will involve both providing general modeling and simulation support as well as representing the translational DMPK group in project teams.
- Build PBPK and PK/PD models to guide dose regimen selection for preclinical studies and clinical trials
- Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize sampling strategies
- Be accountable for expert data integration, analysis, interpretation, and reporting of modeling and simulation results at the project level
- Manage outsourced studies/CROs and prepare related sections of documents for regulatory review
- Represent team in highly collaborative groups across Research, Translational Sciences, and Clinical Development
- Lead collaborations with internal and external partners for scientific research projects
- An advanced degree (PhD or PharmD) in a chemical, biological, pharmaceutical, engineering or related field, 5+ years of relevant experience
- An in depth knowledge of large and small molecule PK/ADME
- Proficiency with modeling softwares (e.g., Matlab, R, Phoenix/WinNonlin, etc) and the ability to analyze and critically assess PKPD data is essential
- Experience in working as DMPK representative in early stage small molecule and biologics project teams to guide candidate selection, PK and PD study design, mechanistic PK/PD modeling and human PK/dose prediction highly desirable
- Experience supporting clinical pharmacology and development of small and large molecules
- Ability to identify key project related questions, build hypotheses and lead a team effort in solving problems
- A proven track record of working effectively in a dynamic, collaborative, team-oriented setting
- Experience with contribution to INDs and other regulatory submissions
- Strong communication and presentation skills in small groups and for large audiences