Director, Regulatory Science (Biologics & Cell & Gene Therapies Development)

Director, Regulatory Science (Biologics & Cell & Gene Therapies Development)

The future of medicine is being shaped today — by breakthroughs in biologics, advanced therapies, and cell & gene innovations that once seemed impossible. At VCLS, we sit at the crossroads of this transformation, guiding pioneering biotech and healthtech companies on their journey from science to patients.

As Director, Regulatory Science – Biologics & Cell & Gene Therapies, you’ll step into a global leadership role with real influence: shaping regulatory strategy, inspiring teams, engaging clients, and strengthening our presence in the US and beyond.

This is an opportunity to be at the forefront of innovation, working with cutting-edge products and helping founders, scientists, and executives navigate complex regulatory pathways.

If you are an experienced consultant with expertise in biologics and advanced therapies — and if you thrive on impact, curiosity, and collaboration — this role is made for you.

What You’ll Do

Regulatory Science Leadership

• Lead a portfolio of clients: earn trust, build long-term partnerships, and act as a strategic advisor.
• Define and execute creative global development strategies for biologics and cell & gene therapies, aligned with client goals, regulatory trends, and market dynamics.
• Integrate VCLS and client teams to act as one collaborative force, engaging proactively with regulatory authorities and leveraging innovative pathways.
• Ensure excellence in delivery while mentoring and developing consultants and regulatory scientists.
• Challenge the status quo to enhance operational efficiency and maximize value for clients.

Local & Cultural Leadership

• Serve as a cultural and commercial figurehead for our US business, championing the PIPE values: People, Innovation, Passion, Excellence.
• Promote engagement and cohesion within the Cambridge team, creating a thriving local presence.
• Act as a brand ambassador for VCLS in the US market, raising visibility, building networks, and attracting top talent.
• Contribute to continuous improvement initiatives, keeping our entrepreneurial spirit alive.

Business Development

• Build and manage client relationships to maximize growth and impact.
• Support business development activities: proposals, budgets, client presentations, and conference participation (as speaker or attendee).
• Represent VCLS as a thought leader in biologics and advanced therapies.

Why Join VCLS?

• Impact: Help bring advanced therapies to patients, guiding some of the most innovative companies in the world.
• Vision: Be part of our bold ambition — 500 life-changing healthtech products delivered by 2050.
• Culture: No silos, no bureaucracy. A science-led, human-driven, future-focused community.
• Opportunity: Lead globally, grow teams, shape strategy, and represent VCLS at the cutting edge of innovation.

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.
• Track record of close interactions with FDA in the context of biologics and cell and gene therapies development.
• A senior regulatory science professional with deep expertise in biologics and cell & gene therapy development.
• Experienced in consulting, able to balance strategy, client delivery, and business growth.
• A strategic thinker with a bias for action, energized by solving complex regulatory challenges.
• A skilled communicator and relationship builder, comfortable advising executives, clients, and regulators.
• A mentor and leader, passionate about developing people and inspiring teams.
• Aligned with our PIPE values and motivated by the chance to leave a legacy in healthcare.