Director, Clinical Operations - Tbwa Chiat/Day Inc

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 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 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, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• 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.
• 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.
• 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.
• 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.

• 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.