Associate Director, Regulatory Science

Job title:

Associate Director, Regulatory Science

Company:

Critical Path Institute – Europe

Job description

ABOUT CRITICAL PATH INSTITUTE (C-PATH)Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies. For over ten years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval. As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker. Our continuing success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world.POSITION OVERVIEWThe Associate Director, Regulatory Science, working with the European Office leadership, and in collaboration with the global C-Path teams, will coordinate our EU funded projects, including, but not limited to, the area of Rare Disease, and support the coordination of specific global efforts led by the European Office. The Associate Director will need to have prior experience with the planning, conduct and management of EU funded projects, as well as internal and external coordination with finance, scientists, regulators and other stakeholders to manage projects, initiatives or events efficiently. This position requires advanced skills and experience in Regulatory Science, with project management, leadership skills and experience in delivering successful outcomes on time, within budget and with high stakeholder satisfaction.SUPERVISORY RESPONSIBILITIESAs the European Office is developing and expanding, the Associate Director may supervise project managers and/or project coordinators.CORE DUTIES/RESPONSIBILITIES

• Lead the operational and project management components of European projects to provide support of cross-functional efforts and serve as point of contact for individual program/project members.

• Represent the C-Path European Office at key conferences and projects meetings.

• Manage resource/budget planning and forecasting, including monthly maintenance and review of finances.

• Prepare reports, summaries, and conducts financial analyses for European projects involving C-Path Regulatory Science core competency.

• Prepare reports and summaries for projects and program key milestones or deliverables.

• Coordinate the development and execution of a detailed work plan and its associated milestones or deliverables to generate, evaluate, and prepare applications for submission to regulatory bodies.

• Facilitate and manage processes for disseminating scientific achievements/advances in peer- reviewed journals and other scientific venues.

• Support developing strong, positive, professional relationships with regulatory authorities, government agencies, research organizations, Foundations, NGOs, etc. (within established policies and compliance standards).

• Work with C-Path central operations/Portfolio Management Office to assess/plan for new projects considering existing and projected workload of existing staff.

• Ability to work independently and in a team-oriented, collaborative environment and adapt to shifting priorities, demands, and timelines.

• Guide and manage execution of cross-consortia/-programmatic plans and track of progress of activities.

• Guide project processes, ensuring consistency, transparency and optimization.

• Oversee/manage planning and execution of key European Office annual meetings and conferences.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Proven experience as a senior-level project manager or program manager, particularly with EU funded projects.

• Strong connections with the rare disease communities.

• Strong negotiation and meeting facilitation skills.

• Demonstrated ability to lead and influence people and teams.

• Excellent communication, organizational, critical thinking, problem-solving and analytical skills.

• Experience working in and managing in a matrix organization.

• At least 2 years of experience working in a remote environment

• Thorough understanding of project/program management techniques and methods.

• Knowledge of performance evaluation and change management principles.

• Ability to meet target deadlines and manage time effectively.

• Ability to build relationships with internal/external stakeholders.

• Exercise sound business judgment when making decisions and adhere to external and internal policies and regulations.

• Ability to successfully anticipate issues or challenges and proactively address without being specifically directed.

• Adapt to shifting priorities, demands, and timelines.

• Practice highest level of integrity and core value system consistent with C-Path’s Standards of Conduct.

• Working knowledge of MS Office suite, and shared document spaces.

• Strong working knowledge of program/project management software.

REQUIRED EDUCATION AND EXPERIENCE

• A bachelor’s degree in a related/relevant field is required. An advanced degree (e.g., MS, MBA, MPH) is preferred.
• Project Manager certification is preferred and/or 7-10 years formal project management experience.
• Advanced knowledge of drug development and EMA/FDA regulatory pathways, with at least 5 years of experience in Regulatory Science and/or other relevant experience.

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any timeJob Posted by ApplicantPro

Expected salary

Location

Dublin

Job date

Fri, 18 Apr 2025 22:15:14 GMT

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