|Reports to:||Director, Project & Alliance Management|
|Department:||G & A|
|Last Updated:||March, 2017|
miRagen Therapeutics, Inc. is a biopharmaceutical company founded to harness the power of microRNA (miRNA) biology. The company combines strong in-house expertise in microRNA biology and chemistry with external partnerships and academic collaborations that leverage best-in-class technologies. Together with its strategic partners, miRagen is focused on the discovery and development of innovative microRNA-based therapeutics in disease areas with high unmet medical need.
miRagen Therapeutics is currently seeking a versatile and highly motivated project manager with proven experience in value driven drug product development for both internal programs, and project and alliance management support on partnered programs. The project manager will be responsible for driving project teams that are focused on developing new treatments for patients, from IND enabling through to product launch.
As a key member of our product development teams, the project manager will support the program lead to coordinate the activities of various departments including pre-clinical IND enabling activities, manufacturing, clinical, translational science, data management, statistics, quality assurance, regulatory, medical writing, external vendors (including collaborators and KOLs), and product commercialization. The project manager is expected to be strategic in planning, team management, process management, and portfolio management. The successful candidate must be able to translate product development strategies into executable plans, and to define and maintain detailed project plans, project budgets, and resource capacity plans. The project manager will be responsible for ensuring that activities are successfully executed and deliverables are created in accordance with corporate and project goals, quality standards, and within project budget.
Primary responsibilities include:
- Strategically plan and prepare integrated project plans and target product profiles
- Ensure functional area “buy-in” and management approval for each integrated project plan and all updates
- Create a change management strategy to support successful project execution and continued stakeholder engagement at all levels in the organization or in the collaboration
- Conduct impact analysis when changes occur, assess change readiness, and identify key stakeholders
- Support the program leader by organizing, scheduling, and facilitating product development team meetings to drive strategy development, make informed decisions, review project plans, and track all action items with a variety of project management tools
- Consult and communicate with functional areas between development team meetings to ensure that project plans and other documentation is updated prior to each development team meeting
- Keep abreast of changes and ensure constant communication with the program leader and all product development team members, so that all members are aware of the impact on start and end dates of project activities, issues, and mitigations
- Coordinate and prepare quarterly dashboards in collaboration with the program leader
- Provide input to the company’s annual operational plans and budgetary process
- Provide coordination and logistical support to Joint Steering Committees (“JSC”) and any operational sub-committees including scheduling meetings, facilitating and tracking the exchange of information, drafting meeting minutes and coordinating calendars
- Work with miRagen and partner representatives to develop integrated project plans for activities conducted under research collaborations
- Work closely with miRagen management, its representatives on these committees, and partner companies to ensure alignment between activities performed under these collaboration and license agreements and miRagen’s strategic, operational and financial planning
- Maintain the integrity of company’s data base and physical legal files for all agreements; proactively identifying where extensions/renewal are required
Suitable candidates will possess a Bachelor’s degree in Life Sciences and 5+ years of pharmaceutical project management experience. Advanced degree and/or PMA or PMP certification desired. Additionally, the ideal candidate will possess a proven ability to effectively work and communicate within a multi-disciplinary team.
- Must have experience in pharmaceutical project management techniques and principles: including project planning, execution and tracking, risk identification, resource, and financial project planning.
- Must be highly proficient with Microsoft Project, Microsoft Excel and Microsoft PowerPoint.
- Knowledgeable in research, preclinical and clinical phases of drug development, ideally with awareness of regulatory, clinical, and commercial aspects of early development.
- Excellent oral and written communication, and presentation skills.
Interested candidates should email a cover letter and resume in PDF format to firstname.lastname@example.org