Director, Clinical Operations
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.
The Director is responsible for oversight of one or more of Pliant’s clinical programs to ensure completion per established project team goals and objectives. The Director will report to the VP, Clinical Operations and 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).
- Accountable for the overall management of assigned clinical programs (across multiple studies), including providing strategic direction to study teams to ensure timely clinical trial execution.
- Responsible for maintaining inspection-readiness across clinical programs.
- Assist in development of hiring/resourcing plans and program budgets.
- Manage multiple direct reports.
- Mentor and oversee junior team members.
- Provide oversight of clinical research organizations (CROs) and other key vendors to ensure timely and quality deliverables.
- Provide a point of escalation for clinical trial execution issues.
- Lead preparation of vendor requirements and project scope and selection of study vendors.
- Responsible for clinical vendor selection.
- Contribute to the establishment of KPIs to measure vendor performance.
- Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data.
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results.
- Oversee set-up and implementation of effective investigator and site monitor training; facilitate operational and therapeutic area training for internal and external study team members.
- Review study invoices and participate in accrual reviews to track the financial status of the study against budget.
- Responsible for establishing clinical operations SOPs, Work Instructions, guidelines, standards, and best practices.
- Drive and implement infrastructure initiatives, process improvements, change management, and ad-hoc business projects.
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.
- 12+ years of experience working with CROs to manage large global clinical trials. Rare disease experience is a plus.
- 3+ years of experience managing direct reports, evidencing strong leadership, team-building, and hands-on management.
- Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices.
- Excellent organizational skills and attention to detail.
- Effective communication and interpersonal skills.
- Able to set priorities, juggle multiple demands, and manage changing priorities.
- Able to think critically and be a proactive problem-solver.
- Able to work independently while exercising initiative, flexibility, and sound judgment.
- Comfortable working with different levels of the company including senior level management.
- Ability to operate in alignment with Pliant’s values and culture.
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 $220,000 - $235,000. 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/.