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 of Regulatory Affairs and Quality Project Management must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, effective, and efficient.

This person will be responsible for managing regulatory milestones from early-stage research through clinical development to registration and will have additional responsibilities supporting the Quality function in developing quality metrics and tracking quality related activities. 

This position serves as an essential partner to both the regulatory strategists and quality team members.  This position will be instrumental in helping to drive the global filings into seamless executions.   This position will also serve as a liaison between Regulatory Affairs and Quality team members and other key development functions.

To be successful in this role, you must be able to provide clear direction, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. This person must have the ability to develop important relationships with key stakeholders, to analyze issues to support relevant and realistic plans, and support program recommendations. In addition, the successful candidate will create an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.

This position will be reporting to Senior Director of Regulatory Affairs.

Responsibilities

• Drive key kick-off regulatory submission meetings (i.e. NDA/MAA/IND/CTAs) as well as key quality meetings (i.e. Quality Council/Review, Inspection readiness) working closely with regulatory and quality team members.
• Facilitate and manage regulatory and quality meetings, including sending out meeting invites, building of agendas, summary of discussion and decisions, capturing meeting minutes and action items.  In addition, proactively setting up any follow up meetings required.
• Ability to support strategic and tactical decisions into action; excellent analytical skills, and to support plans to resolve issues and mitigate risks.
• Develop, track, maintain, and manage program timelines, dashboards, and metrics for both the regulatory and quality function to ensure accurate reporting to enable decision making.
• Use project and regulatory knowledge and facilitation to enable effective teams and meetings.
• Communicate and present program status, issues, and opportunities to stakeholders.
• Identify critical path issues, risks, resource needs and alternative scenarios to achieve objectives.
• Manage team-level and corporate processes effectively, using strong project and process knowledge to drive team deliverables.
• Apply project management expertise, methodologies, department standards and build department templates for multipurpose use.
• Support the development and continuous improvement of processes, procedures, and tools related to program and portfolio management practices.

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.

• Requires a BS degree, advanced degree preferred, in life sciences or business-related field.
• Minimum of 12 years professional experience with 8 years in project management in a pharmaceutical or biotechnology environment. At least 5 of those years in late-stage development.
• Demonstrated understanding of Regulatory and/or drug development processes.
• Experience with global filings (NDAs/MAAs) and a submission background is preferred.
• Experience in Health Agency meeting support is preferred.
• Understanding of Quality operational activities, tasks, and metric is a plus.
• Demonstrated ability to support strategic and tactical decisions into action; excellent analytical skills, and to support plans to resolve issues and mitigate risks.
• Extensive experience with MS Office programs, Microsoft Project (preferred), and other project management tools.
• Strong organizational, project and time management skills.
• Effective communication skills, both written and verbal, which enable successful collaboration with stakeholders.
• Takes accountability for all project management aspects and works collaboratively across teams.
• Expert use of interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
• Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders.
• Sound judgment, problem solving, matrix management, and collaboration in selecting methods and techniques for obtaining solutions to problems.
• Solutions-oriented with strong problem-solving skills.
• Ability to work effectively with cross-functional teams.
• Demonstrated experience coordinating interdisciplinary teams and external vendors.
• Good culture fit with Core 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 $230K – $240K. 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/.