Senior Director, Clinical Operations
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 Director, Clinical Operations, oversees one or more of Pliant’s clinical programs to ensure that they are completed in accordance with the project team’s goals and objectives. The Sr. Director will report to the VP of Clinical Operations and will collaborate closely with a cross-functional team in a fast-paced, high-growth environment to ensure that clinical trials are executed on time, within 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).
This is a unique opportunity for an individual with developed and demonstrated leadership and organizational skills; experience in coaching and managing a team of direct reports; extensive organizational and global clinical operations experience; and technical proficiency in clinical operations frameworks, processes, and systems within an industry context. As the Senior Director, Clinical Operations, your responsibilities will encompass the operational strategy, execution and study conduct, as well as the implementation and oversight of processes, governance, data integrity, and compliance essential to supporting Pliant’s clinical programs and Development Operations. Responsibilities include but are not limited to the following:
Responsibilities
- Accountable for the comprehensive oversight and management of defined clinical programs (across multiple studies), including providing strategic and tactical guidance to study teams to ensure timely operational execution and completion of clinical trials.
- Accountable for ensuring and maintaining inspection-readiness across clinical programs.
- Facilitate the development of hiring and resourcing plans and program budgets.
- Coach and manage multiple direct reports; and mentor junior members of the team
- Provide oversight of clinical research organizations (CROs) and other key vendors to ensure efficient, effective, and high-quality deliverables.
- Provide a point of escalation for issues related to operational execution and risk mitigation.
- Oversee the development of vendor specifications, project scope, and accountable for vendor selection
- Oversee the establishment of KPIs to measure vendor performance.
- Oversee set-up and implementation of effective investigator and site monitor’s training; facilitate operational and therapeutic area training for internal and external study team members.
- Review study invoices and participate in accrual reviews to monitor and track the financial status of the study in relation to the budget.
- Accountable for establishing clinical operations SOPs, Work Instructions, guidelines, standards, related QS documents, and best practices.
- Lead and sponsor infrastructure initiatives, process improvements and enhancements, 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.
- Bachelor’s degree required.
- 15+ years of experience working with CROs to manage large global clinical trials. Rare disease experience is a plus.
- 8+ years of experience managing direct reports, demonstrating effective teamwork, proven leadership, and hands-on coaching and management.
- Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and best practices.
- Exceptional organizational abilities, high attention to detail, and the capability to understand the “overarching” perspective
- Well-developed interpersonal and people-management skills
- Effective communication and presentation skills to internal and external stakeholders at all levels
- Proven capacity to establish priorities and effectively manage several competing priorities and time-sensitive business needs.
- Demonstrates critical and creative thinking, resourcefulness and initiative, and problem-solving skills.
- Exhibits strong capacity to work independently and interdependently while demonstrating initiative, adaptability, and adept judgment
- Comfortable working at all levels of the organization, including senior stakeholders
- Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel
- Ability to demonstrate 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 $280K – $290K. 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/.
