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 Associate Director/Director, CMC Project Management will partner with the Program Lead/Director Program Management and CMC functional leads to manage the integrated CMC project plan including supporting CMC strategy, developing CMC timelines, and ensuring adherence to goals, timelines, and budgets.
- Supports the CMC team with the timely execution of the CMC-related program activities through close collaboration with and direction from the VP, CMC.
- Through proactive communication with the CMC team, modifies and ensures plans are in line with the up-to-date project data and corporate goals.
- Develops, integrates, and maintains CMC-related timelines in conjunction with the technical/ functional leads.
- Partnering with the CMC team proactively identifies risks and develops mitigation plans.
- Organizes effective and efficient CMC team meetings including scheduling, agenda-setting, material preparations, and minutes.
- Ensures identification and timely communication of current CMC-related plans, critical path activities, program process, risks, issues and mitigations to CMC and development product team.
- Tracks departmental decisions, reports, action items, and risks until resolution; escalates issues raised by the CMC team, as needed.
- Facilitates the identification of CMC-related activity interdependencies and potential issues to ensure impact and resourcing constraints are addressed early.
- Awareness of interplay of CMC activities with overall program timelines.
- Tracks timelines and budget actual to plan.
- Partner with functional leads and accounting to develop annual operating plan components related to assigned program.
- Partner with accounting to manage CMC budget including ensuring accurate and timely accruals, identification of out-of-scope activities, and early identification of potential budget variances.
- Track progress against contracts at CMOs.
- Work closely with other functions such as Quality, Regulatory, Clinical Operations to ensure integration of timelines, requirements, and priorities.
- Coordinate and manage special program-related projects, as assigned.
- Performs as part of the Program Management team at Mirum, supporting other cross-functional program activities, as needed
- Contributes to the standardization of project management best practices at Mirum.
- Strong technical background including Bachelors Degree or higher in scientific/healthcare/business field
- Experience (10+ years) in CMC and project management within the pharmaceutical industry (Startup/small pharma experience strongly preferred).
- Experience with late-stage development small molecule programs required; direct experience with CMC activities preferred
Knowledge, Skills, and Abilities:
- Ability to work in a fast-paced virtual environment with demonstrated ability to juggle multiple competing tasks and demands, across time-zones, while maintaining a positive attitude.
- Ability to work independently, take initiative, complete tasks to deadlines, and support product team in doing the same.
- Strong ability to communicate effectively with team members creating an environment that fosters successful teamwork, collaboration, and cooperation.
- Thorough understanding of CMC product development including familiarity with US and EU regulatory requirements.
- Demonstrated ability to prepare timelines and present related information, risks, and potential options and mitigations to differing audiences.
- Demonstrated ability to create and track budgets including communication of overspend/underspend.
- Proven ability to identify risks, propose mitigation strategies, and remove barriers to success.
- Strong attention to detail and the ability to work collaboratively with CMC team to establish priorities for the team.
- Strong knowledge of project management software packages and the Microsoft Office Suite: Excel, Project, PowerPoint, Word, and Outlook; ability to create effective presentations for internal and external use.
- Excellent written and oral communication skills.
- Displays a high level of professionalism with internal and external stakeholders.
- Knowledge of current regulatory requirements and guidelines (e.g., ICH).
To apply, please send your resume to firstname.lastname@example.org.