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Preclinical Gene Therapy Lead

  • UCB - Union Chimique Belge
Leuven, Belgium
Full-time
Published:
  • UCB - Union Chimique Belge
Leuven, Belgium
Full-time
Published:

We are looking for a talented Preclinical Gene Therapy Lead who is agile and innovative to join us in our Early Clinical Development and Translational Sciences group, based in Leuven, Belgium.

ABOUT THE ROLE:

The Preclinical Gene Therapy Lead supports the development of gene therapy programs and ensures that the projects are scientifically robust and positioned for successful transition from early research stage into early clinical development.

Responsibilities include providing scientific direction to project teams on optimal translational strategies and promoting strategic discussions and end-to-end thinking to advance gene therapy candidates throughout the preclinical development stages.

This transversal role in a matrix organization requires strong scientific evxpertise in gene therapy technologies and experience in building translational strategies.

WHO YOU WILL WORK WITH:

Reporting to the Head of Pre-Clinical Gene Therapy you will have the ability to influence project leaders and senior stakeholders, to build successful collaborations across the organization.

YOUR RESPONSIBILITIES:

  • Perform evaluation of Gene Therapy (GT) programs status, progress, challenges and gaps in development ahead of Candidate Selection (CS). Derisk the predictable roadblocks by performing evidence gap assessments and identify program key questions and challenges;

  • Establish strong interactions and involvement with research teams to bridge projects from early research to translational stage. Input and contribute to the design of preclinical studies, including IND-enabling pharmacology and toxicology studies;

  • Build forward-looking translational strategies and provide leadership to project teams on optimal package to allow the transition of GT products from research to translational development phase. Understand and integrate all data generated for a GT project, making sure the data package is robust to declare a Candidate (candidate readiness package);

  • Coordinate the preclinical activities together at the Translational Science level making sure the preclinical projects are supported adequately with the appropriate scientific level;

  • Establish continuous collaboration and integration with the different line functions and departments, including candidates & NPP team, clinical development, regulatory affairs, manufacturing, and quality control, to influence adoption of translational strategy and ensure seamless transition of gene therapy candidates;

  • Contribute to primary due diligence of GT opportunities with Patient Solutions partnering team and monitor journal publications and conference presentations to stay abreast of the latest developments in the field and to support the adoption of future GT assets;

  • Maintain and update knowledge in evolving GT guidelines and in Regulatory Authorities’ nonclinical safety requirements and GLP regulations.


EDUCATION, EXPERIENCE AND SKILLS:

  • You will hold a PhD (or equivalent) degree in Life Sciences, with 8+ years of related work experience in the Pharmaceutical Industry or Biotech/Start-up companies;

  • Have a robust knowledge on translational strategies and experience in gene therapy technologies (3+ years);

  • Specialist knowhow in gene therapy technologies and experience in translational strategies with demonstrated ability to manage drug development projects;

  • Knowledge of FDA, EMA, GLP and ICH regulatory requirements;

  • Excellent interpersonal, verbal and written communication skills. Ability to develop good relationships and strong networks, and to influence key stakeholders to follow functional strategy;

  • Sound leadership skills combined with strong scientific knowledge to rapidly gain credibility with internal colleagues and external partners.


Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you.

ABOUT US:

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

WHY WORK WITH US:

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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