Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.
The Director, Regulatory Project Management will be responsible for project management activities for the Regulatory Department including planning, coordination, and execution of high-quality regulatory submissions of original applications (i.e., NDAs, MAAs, INDs, etc.), rare disease designations, and any subsequent major amendments, supplements, and variations for assigned programs, as needed. The key focus of this position will be to oversee the first regulatory marketing applications for the company. This position will contribute to regulatory submission strategy, working in close collaboration with the regulatory strategy teams, as well as cross-functional teams across the organization (ie, Clinical, Nonclinical, and Quality) to identify submission risks and opportunities, define regulatory deliverables, and build and manage timelines to support regulatory filings through licensure and beyond.
- Responsible for partnering across Regulatory (Strategic Regulatory, CMC Regulatory, Ad-Promo Regulatory, Regulatory International, Regulatory Operations through publishing vendor) and with cross-functional project teams to ensure regulatory timelines and strategies are developed and seamlessly executed upon, enabling successful filings with Global Health Authorities.
- Facilitate and co-lead product/submission-specific multi-disciplinary, cross-functional teams, working with all major contributors, including, but not limited to: Regulatory, Medical Writing, Preclinical, Biostatistics, CMC, QA, etc. to set expectations and ensure timelines are met.
- Develop and actively manages and monitors project timelines and integrated submission project plans to ensure timelines remain on schedule.
- Work with each function in detail to understand the individual deliverables and interdependencies between deliverables, in order to create and maintain an overall project plan timeline across all Modules (Modules 1-5).
- Identify and communicate both regulatory and project risks, with potential solutions to the cross-functional project team and leadership as needed.
- Prepare meeting agendas, meeting minutes and document decisions, action items, and effective issue and risk mitigation plans. Organize and maintain this team information in a central location.
- Prepare and distribute reports and trackers to communicate updates and project status.
- Proactively drive project/submission teams and establish an appropriate level of urgency with a keen focus on deliverables.
- Help manage with the regulatory Lead for each program the review cycles and any follow-up round tables as needed per the filing timelines.
- Create and support policies and Standard Operating Procedures for processes related to global submissions.
- Conduct lessons learned sessions to identify areas for improvement.
- Prepare monthly project reports, communicate and present project status to global project team and senior management.
- Standardize process to view/manage overall, cross-portfolio Regulatory submission workload and view dashboard of submission status.
- Track overview of all major submissions and health authority activity to aid in Regulatory resource planning.
- Support the Head of Regulatory Affairs as required.
- Bachelor’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent), an advanced degree is desirable.
- A minimum of 12 years in the pharmaceutical industry with a minimum of 9 years in Regulatory Affairs with a fluent understanding of drug development.
- Prior project management experience with NDA and MAA submissions and review is required.
- Qualified project management experience; advanced expertise with project management-related software and tools (i.e. MS Project, Sharepoint, Veeva, etc).
- Demonstrated experience in leading decision-making within cross-functional teams.
- Excellent organizational and communication skills, both written and verbal.
- Ability to work independently as well as part of a team environment.
- Positive attitude, energetic and proactive.
- Strong interpersonal skills and the ability to effectively work with others.
- This is a high-growth, fast-paced small organization. The ability to be productive and successful in a work environment is critical.
- Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 5% of work time.
To apply, please send your resume to email@example.com.