Director, Regulatory Affairs and Quality Project ManagementPliant 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.
DescriptionThe 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 and 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 and leadership skills. This person must have the ability to develop important relationships with key stakeholders, analyze issues to support relevant and realistic plans, and support program recommendations.
This position will report to the Senior Director of Regulatory Affairs.
ResponsibilitiesDrive 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 agendas, summarizing discussions and decisions, capturing meeting minutes, and action items.Support strategic and tactical decisions into action; excellent analytical skills 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 functions to ensure accurate reporting.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.Support the development and continuous improvement of processes, procedures, and tools related to program and portfolio management practices.QualificationsTo 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 metrics is a plus.Strong organizational, project, and time management skills.Effective communication skills, both written and verbal, which enable successful collaboration with stakeholders.Expert use of interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.Sound judgment, problem-solving, matrix management, and collaboration in selecting methods and techniques for obtaining solutions to problems.Ability to work effectively with cross-functional teams.Good culture fit with Core Values.
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