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. The company recently reported positive data from its Phase 2a trial in IPF and is currently ramping up activities in preparation for a late-stage clinical trial at worldwide sites.
Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant is initiating a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. 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.
Description
The Drug Metabolism and Pharmacokinetics (DMPK) department and Pliant is seeking a highly motivated Sr Manager to join our dynamic and collaborative team. Reporting to the Sr Director, DMPK, the successful candidate has a proven track record of working within multi-disciplinary project teams as the primary DMPK point of contact and subject matter expert in Pharmacokinetics.
Responsibilities
- Design, interpret, and report preclinical in vitro and in vivo PK, PD, and ADME studies for target validation and candidate selection.
- Build (PB)PK and PK/PD models to guide dose regimen selection for preclinical studies and clinical trials.
- Represent team in collaborations with internal and external partners for scientific research projects and manage outsourced studies/CROs.
- Write ADME and pharmacokinetic reports and regulatory documents (IB, IND/IMPD).
- Build open and honest collaborative relationships within and outside the DMPK function.
- Coach and manage junior staff to foster a highly innovative mindset and guide development of new assays, being a role model for scientific excellence.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.
- An advanced degree (PhD or PharmD) in a chemical, biological, pharmaceutical, engineering, or related field with 4+ years of relevant work experience, or MS with 10+ years of experience.
- An in-depth knowledge of small molecule PK/ADME.
- 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.
- Proficiency with modeling software (e.g., Matlab, R, Phoenix/WinNonlin, etc) and the ability to analyze and critically assess PKPD data is preferred.
- Ability to identify key project related questions, build hypotheses and lead a team effort in solving problems.
- Experience with contribution to INDs and other regulatory submissions.
- A proven track record of working effectively in a dynamic, collaborative, team-oriented setting.
- Strong organizational, communication and presentation skills in small groups and for larger audiences.
Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
The annual base salary for this role is $160,000 - $176,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.
To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.