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.
* 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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