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

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

VCLSSomerville, NJ, US
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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.
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    Director Regulatory • Somerville, NJ, US