Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
The CMC Project Manager will partner with the Program Lead/Director Program Management and CMC functional leads to further develop and manage the integrated CMC project plan including supporting strategy, developing timelines, and ensuring adherence to the budget for our cholestatic liver disease programs.
- Supports the CMC team with setting, prioritizing, and the timely execution of the CMC-related program activities. Proactively modifies and ensures plans are in line with most up-to-date project data and corporate goals.
- Develops, integrates and maintains CMC-related timelines in conjunction with the technical/ functional leads. Proactively identifies risks and partners with the CMC team to develop mitigation plans.
- Manages effective and efficient CMC team meetings including scheduling, agenda setting, material preparations, and minutes.
- Ensures identification and timely communication of CMC-related plans, critical path activities, program process, risks, issues and mitigations to CMC and development product team.
- Develops and maintains CMC-related risk tracker by communicating with technical leads on a regular basis and proposes potential risk mitigation.
- Tracks departmental 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 with program timelines.
- Tracks timelines and budget actual to planned.
- 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.
- Coordinate and manage special program-related projects, as assigned.
- Contributes to the standardization of project management best practices at Mirum.
- Bachelors Degree or higher in scientific/healthcare/business field.
- Experience (5+ years) in CMC and project management within the pharmaceutical industry (Startup/small pharma experience preferred).
- Experience with late stage development small molecule programs desired.
Knowledge, Skills and Abilities:
- Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands, across time-zones, while maintaining 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 requirements.
- Demonstrated ability to prepare timelines and present related information to management.
- Demonstrated ability to create and manage 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 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.