Pliant Therapeutics is a late-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 diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.
The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.
Pliant is conducting 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.
Description
The Senior Clinical Trial Manager is responsible for managing the day-to-day operations of assigned clinical studies to ensure completion per established project team goals and objectives. The Sr. CTM 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.
Responsibilities
- Lead internal cross-functional study team for assigned studies to identify risks and mitigation strategies.
- Manage the day-to-day operations of assigned studies.
- Review and edit of relevant documents including protocols, informed consent forms, case report forms
- Coordinate clinical study timelines with Project Management and escalate issues that may impact timelines/deliverables.
- Manage clinical research organizations (CROs) and oversee management of other vendors to ensure timely and quality deliverables.
- Lead preparation of vendor requirements and project scope and selection of study vendors.
- Lead feasibility assessment and selection of countries and sites for study conduct.
- Implement appropriate systems, standards and processes to ensure quality at the level
- of investigative sites, vendors and data.
- Oversee maintenance of clinical trial master files.
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability.
- of top line results; participate in data reviews.
- Author, audit and/or edit study plans/procedures/guidelines and ensure their timely implementation.
- Author, audit and/or edit written summaries of data reports, presentations, training
- material, and study documents (including pharmacy, laboratory, and operations manuals).
- Ensure set-up and implementation of effective investigator and site monitor training;
- coordinate operational and therapeutic area training for internal and external study team members.
- Create and conduct study-specific training at investigator meetings.
- Assists with Inspection Readiness activities which may require development, modification and/or implementation of policies as needed to ensure high quality and integrity.
- Review study invoices and participate in accrual reviews to track the financial status of the study against budget.
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company 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.
- 8+ years of experience, including CRO management in support of global clinical programs.
- 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.
- Experience managing or mentoring junior-level Clinical Operations or administrative staff
- Comfortable working with different levels of the company including senior level management.
- Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.
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 $165,000 - $175,000. 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/.