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Let's push the boundaries together and make the most of your talents!

Biomarker Lead

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Research & Early Development
Job ID:  69535

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

Biomarker Lead

 

Location: Braine l'Alleud

 

The Translational Medicine (TM) Biomarker Lead is accountable for devising the biomarker strategy for assigned projects across their development lifecycle ie from the pre-clinical phase to clinical proof of concept, and potentially through to late development/market. This will include identifying and proposing innovative and feasible biomarkers aligned to the clinical development strategy to support clear and efficient decision making, optimal targeting of the drug to specific patient populations and enhancing overall probability of successful drug development and approval.

 

The TM Biomarker Lead will be considered a UCB Subject Matter Expert in biomarker technologies, their development and implementation. The role will therefore require deep understanding and appreciation of the scientific, technical, regulatory, intellectual property and preferably commercial considerations for successful biomarker implementation to drug development programmes.

 

The TM Biomarker Lead will be required to work closely with all members of the Project team and Clinical Subteam responsible for delivering the clinical development strategy. The role will include leadership of the Biomarker Subteam (a multidisiplinary team including members from Translational Biomarkers and Bioanalytics, Non Clinical Safety and Clinical) which is responsible for delivery of the biomarker strategy to time and budget. The encumbent thereby is required to have not only strong technical and strategic abilities, but excellent interpersonal and negotiation skills.

 

Major accountabilities 

 

Strategy and leadership

 

The role holder will: 

•           Lead the project biomarker subteam to deliver appropriate planning and operationalization for translational and clinical biomarker strategies as and when required

•           Work to support the development and adoption of biomarker led drug development strategies in UCB Project teams to add value to drug projects.

•           Ensure that biomarker assays and diagnostic tests are delivered to rigorous scientific and technical standards, whilst being synchronised with the timing of clinical trials and meeting regulatory standards to demonstrate analytical validation and clinical utility

•           Work with UCB regulatory experts to assist in regulatory responses in respect of  biomarker development

•           Work with internal and external scientific experts to review biomarker practice and establish a scientific and technical knowledge base of available biomarker assays and appropriate assay platforms together with appropriate organisational partners for their delivery

 

Operational delivery

 

The role holder will: 

•           Agree strategic objectives, high-level project plan and milestones with UCB project teams

•           Be accountable for the delivery of agreed plans to time, budget and quality and provide updates on the progress, risks and opportunities of the agreed plans to the appropriate governance bodies for review

•           Identify, manage and mitigate risk to delivery

 

Interested? For this position you’ll need the following education, experience and skills:

 

  • Strong understanding of the implementation and use biomarkers in an industrial drug development environment. Spanning early discovery to late stage patient stratification.
  • Good knowledge of (early) clinical development with proven track record of successful contribution to projects.
  • Proven track record of contacts with academic experts in experimental medicine techniques related to the research areas of interest to UCB (CNS, Immunology)
  • Neuroscience background/ PhD in Neuroscience, with deep understanding of Neuroscience, especially Neurodegeneration or Epilepsy or Neuroinflammation

  • Knowledge of overall drug development process. 

  • Credible, in-depth knowledge and experience of the implementation of biomarkers in drug development with understanding of the clinical application of such markers, their evaluation and analysis and ideally linkage between the biomarker as surrogate marker and the clinical endpoint(s).

  • Ability to present a well reasoned business case, and influence other departmental leaders to support cross functional implementation of new initiatives and projects.

  • Ability to communicate effectively with internal and external opinion leaders including pharmaceutical regulatory agencies, e.g. FDA, EMEA.

  • Ability to work in a matrix type environment.

  • High performer, strong team-commitment. Is innovative, can manage uncertainty. Ability to work independently and to solve complex problems and multiple projects in supervisory capacity. Must be a strong team player with abilities to work in a multicultural environment. Empowers and coaches teams to interpret and synthesize information that leads to insights.

 

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

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. 

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