Director, Regulatory Affairs and Quality Project Management

July 23

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Pliant Therapeutics

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We are transforming the lives of patients by developing best-in-class treatments for fibrotic diseases.

fibrosis • integrins • muscle biology • oncology • Duchenne muscular dystrophy

51 - 200

💰 $287.5M Post-IPO Equity on 2023-01

Description

• Manage regulatory milestones from early-stage research through clinical development to registration • Support the Quality function in developing quality metrics and tracking quality related activities • Drive the global filings into seamless executions • Liaison between Regulatory Affairs and Quality team members and other key development functions • Provide clear direction, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills • Develop important relationships with key stakeholders, analyze issues to support relevant and realistic plans, and support program recommendations • Create an environment in which the team is highly motivated and engaged to work collaboratively

Requirements

• 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

Benefits

• Benefits • Equity • Annual target bonus for fulltime positions