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 Senior Clinical Research Associate (Sr. CRA) is responsible for assisting the Clinical Trial Manager or Sr. Clinical Trial Manager in managing and/or leading the day-to-day operations of assigned study execution tasks to ensure completion per established project team goals and objectives. The Sr. CRA will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical trials are conducted on time and budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.
This is a hybrid position, with a 3 day in the office expectation (South San Francisco).
Responsibilities
- Participate in preparation of vendor requirements and project scope and selection of study vendors.
- Manage vendors to ensure timely and quality deliverables (e.g. central laboratory, imaging).
- Provide study progress updates to CTM and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
- Provide monitoring oversight through review of monitoring schedules, metrics, and reports.
- Participate in study monitoring visits, including CRA oversight visits.
- Participate in and, if appropriate, facilitate cross-functional study execution team meetings; liaise with other functional areas to coordinate clinical study activities.
- Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
- Develop study plans and participate in system set-up (e.g. UAT of EDC, IRT).
- Participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
- Review clinical study plans, reports, and study metrics.
- Participate in study feasibility assessments and selection of countries and sites for study conduct.
- Participate in creation and conduct of study-specific training at investigator meetings.
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with Pliant SOPs.
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.
- Bachelor’s degree required.
- 3-6 years of experience, including 2-3 years of vendor management experience (e.g. imaging, central lab, IRT).
- Excellent organizational skills and attention to detail.
- Effective communication and interpersonal skills.
- Able to set priorities and juggle multiple demands.
- Able to think critically and be a proactive problem-solver.
- Able to work independently while exercising initiative, flexibility and sound judgment.
- Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.
- Ability to operate in alignment with Pliant’s values.
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 $98,000 - $110,000. 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/.
