X4 Pharmaceuticals INC
Director, Strategic Project Management - Clinical Development
X4 Pharmaceuticals INC, Boston, Massachusetts, us, 02298
Director, Strategic Project Management - Clinical Development and Safety
Reporting to:
Global Head of Clinical Development and Safety
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.
This opportunity will …
Align with your values and grit, and passion for innovative science.
Leverage your deep knowledge of Clinical Development 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 Development and Safety is a pivotal role that offers strategic project management expertise to support the Clinical Development and Safety team. This role requires a comprehensive understanding of Clinical Development 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 Development and Safety. The Director will also play a key role in developing and driving the Clinical Development Plan (CDP) and strategic Clinical Development initiatives. Key activities will include managing critical projects, planning for and coordinating external data dissemination initiatives, and ensuring the overall efficiency and effectiveness of the Clinical Development and Safety team. Reporting to the Global Head of Clinical Development and Safety, this role is responsible to:
Utilize strategic project management skills to provide support activities across Clinical Development and across functions, including Biometrics, Data Management, Clinical Operations, Medical Affairs, Regulatory, and Safety & Pharmacovigilance.
Partner with Senior Medical Directors and key study team leads to enhance the team’s effectiveness in decision making and delivery.
Manage project plans for specific activities and deliverables within Clinical Development and Safety and cross-functionally, as well as 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 Development, through the CDP and integrated with the Medical Affairs Plan, in partnership with the Global Head of Clinical Development and Safety.
Partner with finance and the Clinical Development and Safety team to establish study budget templates and coordinate efforts for and provide guidance on monthly/quarterly/annual/LRP forecasting and budget activities within Clinical Development and Safety and across the Integrated Clinical Development Team.
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 Development and Safety 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.
Strong strategic planning and execution skills and experience in the creation, management, and oversight of long-range CDPs.
Demonstrated ability to drive cross-functional teams to establish priorities focused on the critical path and identify key risks and mitigations.
Demonstrated in-depth knowledge and experience in planning, management, and oversight of activities and deliverables within Clinical Development.
Strong knowledge of Clinical Development concepts and ability to implement Clinical Development practices, processes, and procedures.
Proven experience with successful management of and interactions with CROs, vendors, and other external vendors.
Proven track record of successfully 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 Development and Safety project management activities with a broader Project Management team and at the cross-functional team level.
Ability to design, implement and lead multiple projects, setting deadlines, assigning accountabilities and 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.
About Us
Pipeline
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.
#LI-Hybrid
#J-18808-Ljbffr
Reporting to:
Global Head of Clinical Development and Safety
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.
This opportunity will …
Align with your values and grit, and passion for innovative science.
Leverage your deep knowledge of Clinical Development 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 Development and Safety is a pivotal role that offers strategic project management expertise to support the Clinical Development and Safety team. This role requires a comprehensive understanding of Clinical Development 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 Development and Safety. The Director will also play a key role in developing and driving the Clinical Development Plan (CDP) and strategic Clinical Development initiatives. Key activities will include managing critical projects, planning for and coordinating external data dissemination initiatives, and ensuring the overall efficiency and effectiveness of the Clinical Development and Safety team. Reporting to the Global Head of Clinical Development and Safety, this role is responsible to:
Utilize strategic project management skills to provide support activities across Clinical Development and across functions, including Biometrics, Data Management, Clinical Operations, Medical Affairs, Regulatory, and Safety & Pharmacovigilance.
Partner with Senior Medical Directors and key study team leads to enhance the team’s effectiveness in decision making and delivery.
Manage project plans for specific activities and deliverables within Clinical Development and Safety and cross-functionally, as well as 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 Development, through the CDP and integrated with the Medical Affairs Plan, in partnership with the Global Head of Clinical Development and Safety.
Partner with finance and the Clinical Development and Safety team to establish study budget templates and coordinate efforts for and provide guidance on monthly/quarterly/annual/LRP forecasting and budget activities within Clinical Development and Safety and across the Integrated Clinical Development Team.
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 Development and Safety 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.
Strong strategic planning and execution skills and experience in the creation, management, and oversight of long-range CDPs.
Demonstrated ability to drive cross-functional teams to establish priorities focused on the critical path and identify key risks and mitigations.
Demonstrated in-depth knowledge and experience in planning, management, and oversight of activities and deliverables within Clinical Development.
Strong knowledge of Clinical Development concepts and ability to implement Clinical Development practices, processes, and procedures.
Proven experience with successful management of and interactions with CROs, vendors, and other external vendors.
Proven track record of successfully 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 Development and Safety project management activities with a broader Project Management team and at the cross-functional team level.
Ability to design, implement and lead multiple projects, setting deadlines, assigning accountabilities and 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.
About Us
Pipeline
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.
#LI-Hybrid
#J-18808-Ljbffr