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Negotiable Salary
VCLS
Cambridge, MA, USA
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ShareSenior Director, Regulatory Science - Biologics & Cell and Gene Therapies Development Expertise This is a US & Global Regulatory leadership role that will see you driving regulatory strategy, client engagement, team leadership, continuous improvement initiatives and being a cultural and commercial figurehead for US Business. You will ensure operational excellence while fostering creativity, unconventional innovation, team growth, and a thriving local presence in our Cambridge office. Key Responsibilities: Regulatory Science Leadership: Manage a portfolio of clients: establish relationships with client, monitor client satisfaction, grow business with each client and trust from all of them,by thinking strategically about client needs and how to align VCLS activities in a customized manner. Define and execute custom and creative global drug development strategies towards product registration and commercially sustainable launch, aligned with client goals, current and upcoming regulations and market trends. Integrate and lead VCLS and client teams to act as one towards achieving client goals, working in close collaboration with regulatory authorities, especially when using innovative regulatory pathways. Lead high-quality delivery of services while mentoring and growing the team. Enhance operational efficiency to deliver high added value with lean teams and efficient tools, and by challenging the status quo. Local Leadership: Promote VCLS values and culture internally by fostering local team engagement and cohesion via client centricity. Serve as a brand ambassador in the US market, driving visibility and recruitment of top talent. Contribute to the vision, strategy, and prioritization of continuous improvement initiatives to increase efficiency of key processes. Maintain entrepreneurial spirit. Business Development: Build and manage client relationships to maximize revenue and growth. Support business development through initial contact, proposal writing and budgeting, client presentations, participation in conferences as a speaker or attendee. Requirements Advanced degree in a scientific discipline (e.g., Ph.D., MD, Pharm.D.) or related field. 12+ years of experience in regulatory science with leadership expertise and creative thinking. Strong understanding of global regulatory guidance and consulting practices in life sciences and in particular in the development of cell and gene therapies, Proven leadership, team management, and strategic planning skills. Track record of close interactions with FDA in the context of biologics and cell and gene therapies development.
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New York, NY, USA