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Description
The Director of Clinical Affairs Program Management leads and coordinates program management activities for clinical projects and / or clinical programs.
The Director will work with the representatives from Clinical Affairs functional teams (Site Operations, Lab Operations, Data Management) to ensure timely deliverables to Regulatory Affairs or other stakeholders.
This role is focused on coordinating Clinical Affairs functions in the management and execution of the Clinical Affairs project roadmap.
The Director will manage a group of Project Managers to assist the functional teams in the execution of the product roadmap.
In addition, this role requires managing the annual Clinical Affairs budget, long range planning, prioritization of projects (in alignment with company priorities), and working with Clinical Affairs functional leads for resource allocation.
The Director will be responsible for implementing and driving the use of the processes and continuous improvement processes. Job Responsibilities :
- In conjunction with CA functional heads, is accountable for and leads the definition and implementation of clinical project plans, including project scope and objectives, budget, timelines and critical milestones, as well as the identification and monitoring of clinical projects risks’ and corresponding mitigation plans.
- Leads the clinical project / program by managing the collaborative activities of the clinical team and facilitating any project interfaces which contribute to reaching clinical study goals.
- Leads project / portfolio periodic reviews. Ultimately, monitor and report progress against objectives to appropriate stakeholders.
Builds, maintains and analyzes related clinical studies KPI and take actions.
- Identify, prioritize and proactively monitor changes that may affect the project(s). Authorizes and / or escalates as needed.
- Coordinates the periodic budget / LBE processes : set-up tools and processes, responsible with CA peers of the budget consolidation, interface with programs and projects and CA resources managers.
- Sets-up and promotes project management best practices and processes across Clinical Affairs teams
- Coaches and mentors team members and assists them in solving problems relating to project management
- Assists with the CA management for anticipating further needs and strategic orientations
Minimum Qualifications : Education / experience requirements :
- B.S. in a technical field.
- MS / MBA / PhD preferred, PMP certification preferred
- 10 years of relevant experience in project and program management in regulated environment and ideally experience in portfolio management.
Skill requirements :
- Project management methodology
- Excellent organizational skills
- Excellent oral and written communication skills - English fluent
- Ability to drive a multitude of department programs and projects according to company priorities
- Relationship building / Teamwork and Collaboration
- Negotiation
- Flexibility
- Impact, Influence Decision making
- Strategic orientation
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