Date: Mar 7, 2019
Location: Braine L'alleud, Walloon Brabant, BE
UCB has a strong market presence in more than 40 countries, € 3.88 billion in revenue (2015), 7,500 employees and numerous strategic partnerships across the industry. It is Headquartered in Brussels, Belgium.
UCB is a patient-centric global biopharmaceutical leader transforming the lives of people living with severe diseases. This strategy involves focusing on severe diseases in three therapeutic areas: Central Nervous System and Immunology as well as Bone disease. UCB also has a selective presence in primary care. As severe diseases are treated by a relatively small number of specialists, UCB has a close relationship and regular dialogue with physicians and their patients - an essential ingredient for understanding and addressing the daily physical and social symptoms of these diseases. Severe diseases also require a smaller sales force, so more resources can be devoted to R&D and other functions.
Within the New Medicine Patient value Unit located in Braine L'Alleud close to Brussels, we are now looking for a (m/f)
Job nature and scope
The Translational Medicine (TM) Biomarker Lead is accountable for devising the biomarker strategy for assigned projects across their development lifecycle ie from 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 decision making (eg proof of mechanism/concept), enable stratified medicine/diagnostic approaches (where appropriate), and overall enhance the probability of successful development and approval of the asset.
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.
Strategy and leadership
The role holder will...
* Lead the clinical science team to delivery appropriate planning and operationalization for biomarker and early clinical 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
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
Education , Experience and skills
* PhD in Neurosciences
* 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).
* deep understanding of Neuroscience, especially Neurodegeneration or Epilepsie 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.
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