Senior Director, Regulatory Science

Senior 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.