Non-Clinical Safety Lead

Contenuto del lavoro

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our Investigative Toxicology (iTox), Development Sciencesteam, we are looking for a high caliber, self-motivated,Non-clinical Safety Lead with Drug Discovery Experiencebased in Braine l’Alleud, Belgium ; Slough, UK or Boston, US.

The investigative toxicology (iTox) team is positioned within the Non-Clinical Safety Evaluation function of Development Sciences, which as a department provides strategy and support in integrated non-clinical safety, pathology, pharmacokinetics/pharmacodynamics and DMPK, bioanalysis and biomarkers, immunogenicity, and regulatory activities throughout the lifespan of projects, from target identification through to clinical studies. The iTox team operates and collaborates closely with colleagues in Development Sciences and across the Research & Development organization to support GLP and non-GLP in silico, in vitro and in vivo non-clinical safety activities.

You Like To Work In Anenvironment Where

• You will provide non-clinical safety support to multiple drug formats including small molecules, biologics and emerging new formats such as gene therapy or Protacs through discovery and possibly development phases.
• You will build and deliver non-clinical safety strategies to global project teams from Discovery Research and possibly through to Submission.
• You will demonstrate high skills in toxicology interpretation/project contextualization and issue resolution; you will participate in various toxicology and R&D initiatives including cross-functional collaborations internally and externally via pharma scientific consortia.
• You will work in a collaborative environment and as a member of interdisciplinary project teams and in close collaborations with subject matter experts from all safety assessment disciplines.
• You will influence the portfolio from target entrance through all stages of discovery and possibly development and will represent UCB in meetings with Health Authorities.
  

You Will Contributeby

Non-clinical Project Representative & Science

• Represents Development Sciences on the drug project teams.
• Responsible for the non-clinical characterization and optimization of NCEs and NBEs (from screening to the selection of new candidate drugs).
• Designs innovative non-clinical safety programmes based on the target, chemical space and intended disease indication and patient population.
• Delivers complex projects to time and in line with the target organ safety strategies.
• Presents scientific data, their interpretation and contextualisation to the project teams.
• Provides investigative solutions for non-clinical project issues by utilizing standard, state of the art and novel approaches, including recommendation to discontinue working on lead/candidate drugs.
• Operates a risk/benefit and/or risk mitigation approach for each project. Advises project teams on requirements and risks for each project phase (hit identification/lead optimisation/candidate drug selection).
• Collaborates effectively with the scientific Subject Matter Experts (SMEs) to deliver compound testing and data interpretation.
• Collaborates effectively with other Dev. Sciences’ departmental representatives (ADME, DMPK, Biomarker/Translational, Quantitative Pharmacology).
• Builds strong collaborations inside and outside UCB; building trust.
• Recognizes, anticipates and addresses cross-functional conflict in a constructive manner.
• Operates effectively in a matrix environment, if required, leading non-clinical sub-teams and cross-functional investigative teams.
• Communicates effectively.
• Influences Dev. Sciences stakeholders and drug project teams to embrace non-clinical requirements and goals.
• Keeps atop of scientific, technological and strategic developments related to their field of work. Maintains awareness of relevant aspects in relation to toxicology by reading scientific literature and by participating in relevant scientific conferences and training courses.
• Contributes to scientific standing of UCB by publishing and presenting in reputable forums (abstracts, posters, journal publications).
• Requests non-clinical studies (in silico, in vitro, in vivo) in line with internal and external guidelines.
• Prepares and/or reviews study reports, and if required, regulatory documents.
• Responsible for an efficient hand over of the candidate drug; or may take the drug candidate into early development.
  

Functional Representation

• As functional representative, understand the functional consensus view, and if required, establishes the functional consensus via discussion at internal decision making meetings and governance forums.
• Ensure Dev. Sciences’ project recommendations are clear and visible at governance interactions (e.g Discovery Portfolio Meeting).
• Updates the management leadership team to facilitate their understanding of non-clinical project issues, not limited to but in particular, before project governance interactions.
• Represents UCB in the field of toxicology as a member of a scientific society and ideally, a member of a scientific committee.
  

Strategy

• Contributes to team documents (e.g. role descriptors) and team strategy;
• Promotes the visibility of Discovery and Translation Safety.
  

Other

• Adheres to rules concerning animal ethics, 3Rs, GLP and SHE.
• Works according to the UCB Code of Conduct.
• Works according to the Therapy Areas, Discovery Science and Translational Medicines Group Charter.
  

Interested? For this position you’ll need the followingeducation, experienceandskills:

• You must hold a DVM, or Ph.D. in a field related to toxicology (pharmacology, biomedical science, immunology, neuroscience) and have an in-depth knowledge of the biology and pharmacology associated with the immune or neuroscience therapeutic areas in term of non-clinical safety assessment with an emphasis on the earlier drug discovery phases. You have an extensive experience of drug discovery support, mechanistic and investigative toxicology, safety assessment related disciplines and regulatory toxicology in the pharmaceutical industry.
• General Toxicologist with broad knowledge of non-clinical safety assessment gained in pharmaceutical R&D (NBEs and NCEs).
• Has a good understanding of disciplines other than toxicology such as in silico, in vitro and/or in vivo experience, pharmacology, DMPK, clinical pharmacology, regulatory affairs etc.).
  

Due to the nature of the position, the following desirable assets are desired:

• Project management experience
• Excellent interpersonal skills to facilitate interactions; excellent oral and written English communication skills. Demonstrated technical writing skills.
• Demonstrated problem-solving, strong decision-making, and innovative mindset.
• Demonstrated critical mindset in relation to experimental study design, data analysis, interpretation and contextualisation.
• Demonstrated ability to work independently and as a strong collaborative member of diverse teams.
• Open, confident, and persuasive behaviour, succeeding through influence, experience in balancing big picture thinking with detailed analysis, ability to be flexible and to adapt to a changing environment.
  

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

About Us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

Curious to know more? Please visit our website www.ucb.com .

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.