Director, Strategic Project Management - Clinical Operations
Reporting to : Vice President, Clinical Operations
Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases?
Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the lives of people with limited to no treatment options?
Named one of the Top Places to Work in 2023 by The Boston Globe, X4 is an exceptional place, focused on open communication and collaboration and dedicated to each other, our partners, and the medical community.
With the April 2024 U.S. approval of our first drug XOLREMDI (mavorixafor), we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company.
But there is so much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial.
In addition, our research team in Vienna, Austria is focusing on new drug discovery and examining the genetic causes of chronic neutropenic disorders.
We recognize that developing innovative, new medicines is challenging, but we embrace this challenge to truly make progress for patients each day.
If you feel you would be a good fit for X4, we invite you to share with us your aspirations and career goals.
This opportunity will
- Align with your values and grit, and passion for innovative science.
- Leverage your deep knowledge of Clinical Operations to support our innovative science and allow you to have a major impact on our mission to support our patients.
- Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.
Accountabilities and Responsibilities :
The Director, Strategic Project Management - Clinical Operations is a pivotal role that offers strategic project management expertise to support the Clinical Operations team.
This role is not a study management position but necessitates a comprehensive understanding of Clinical Operations and a strong emphasis on project management and strategic thinking.
This role will act as a central point of coordination and leadership, ensuring seamless communication and effective collaboration in Clinical Operations.
The Director will also play a key role in driving strategic Clinical Operations initiatives, managing critical projects, and ensuring the overall efficiency and effectiveness of the Clinical Operations team.
Reporting to the Vice President, Clinical Operations, this role is responsible for :
- Provide strategic project management skills to support activities across Clinical Operations and cross-functionally
- Partner with Clinical Study Leads to enhance the team’s effectiveness in decision making and delivery; facilitating communication and creation, maintenance, and drive of timelines to keep studies and projects on schedule.
This includes overall project planning, but also specific deliverables during the course of study planning and conduct.
- Manage project plans for specific activities and deliverables within Clinical Operations, cross-functionally, and with third party vendors
- Establish and maintain cross-functionally integrated project plans / timelines and accurately track and provide timely reporting on progress
- Contribute to development of mid and long-term strategy for Clinical Operations in partnership with the Vice President, Clinical Operations
- Partner with finance and the Clinical Operations team to establish study budget templates and coordinate efforts for and provide guidance on monthly / quarterly / annual / LRP forecasting and budget activities
- Schedule, organize, and drive team meeting(s), prepare and distribute agendas, minutes, and maintain action and decision logs
- Coordinate activities with project managers from other functions around resources, timelines, and deliverables as applicable
- Support vendor identification, onboarding, and governance (including management of KPIs, dashboards, etc.)
- Oversee and ensure tracking and movement with Clinical Operations SOPs and work with Quality to track compliance issues to completion
- Assist in managing and coordinating cross-program and cross-function activities
Requirements : Proven Experience, Skills, and Education :
- Bachelor’s Degree required; Advanced degree preferred
- 10+ years of experience in the biotech / pharmaceutical industry with direct experience in project management in the Clinical Development space
- Demonstrated in depth knowledge and experience in planning, management, and oversight of activities and deliverables within Clinical Operations
- Strong knowledge of and ability to implement Clinical Operations concepts and operational practices
- Proven experience with successful management and interaction with CROs, vendors, and other external vendors
- Proven track record of managing multiple projects and / or programs concurrently
- Deep knowledge and ability to use project management software and tools, as well as Smartsheet
- Ability to effectively represent Clinical Operations project management activities with a broader Project Management team and at the cross-functional team level
- Experience in strategic planning and execution, and developing and implementing processes and procedures
- Ability to design, implement and lead multiple projects, setting deadlines, assigning responsibilities, and monitoring progress towards goals
This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days / week in the office.
We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!
X4 Pharmaceuticals is an Equal Opportunity, and Affirmative Action Employer committed to a culturally diverse workforce.
All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.
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