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

Senior Clinical Program Director

Location: 

Monheim, Mettmann, Germany

Job Function:  Clinical Development
Job ID:  65297

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?


To strengthen our Global Clinical Development community and our Patient Value Neurology Solutions organization, we are looking to fill the position of a Senior Clinical Program Director, based in our UCB sites in Monheim, Germany; Brussels, Belgium (headquarters); Slough, UK or Raleigh, NC  


As a Lead Clinical Development Representative at UCB you like to work in an environment where you

  • Are accountable for all clinical aspects of the assigned NBE program
  • Serve as a matrix leader for Clinical Program Directors who are leading the development for specific patient populations within the program
  • Maintain excellent working relationships with internal and external stakeholders to ensure patient-driven and patient-oriented clinical programs, based on broad medical, scientific, regulatory, commercial and external input
  • Lead and ensure adequate evidence planning and implementation of the clinical development strategy to enable successful regulatory filing, approval and launch


You will 

  • Lead the development and subsequent revisions of the Clinical Development Plan (CDP) ensuring compatibility with the Target Patient Value Profile (TPVP) and representing contemporary and innovative research approaches.
  • Ensure that study concepts and protocols are of high quality, represent contemporary research approaches, are aligned with related CDPs and TPVPs, and are appropriately managed by the clinical study teams.
  • Develop a strong knowledge base of the relevant disease area and therapeutics and become the company expert for the respective treatment modality.
  • Develop and Maintain excellent working relationships and global cross functional collaboration together with all necessary stakeholders to ensure broad medical, scientific, regulatory, commercial and external input into the clinical programs.
  • In conjunction with the Safety Lead and Program Physicians, oversee the ongoing evaluation of the benefit/risk ratio of the asset.
  • Contribute to the ongoing safety evaluation of a product with review of and/or contributions to aggregate reports and revisions to Company Core Data Sheet and labels.
  • Ensure compliance of program(s) with all appropriate regulations, SOPs, company processes and ICH GCP and quality standards applicable to UCB.
  • Lead the team in the planning and execution, and be accountable for the on-time delivery, of high-quality clinical components of global regulatory submissions.
  • Represent the company at meetings with Regulatory Authorities, partners, conferences, and advisory boards.
  • In conjunction with the Publications Team, serve as co-author and/or reviewer of scientific publications of results of clinical programs.

 

 

 

Interested? For this position you’ll need the following educationexperience and skills:

  • Master’s Degree required with a PharmD, PhD or MD preferred
  • Depending on previous professional experience, 7-10 years of relevant experience in biopharmaceutical-clinical development is required, including oversight of the planning and simultaneous management and reporting of multiple clinical studies
  • Strong strategic and innovative leadership
  • Experience in rare diseases and/or neurological/hematological indications preferred
  • A participative management style
  • Ability to build effective transversal relationships with internal stakeholders at all levels in the organization
  • Leader in a matrix type environment with strong focus on value creation
  • Demonstrates clear and articulate verbal, written and presentation skills with excellent command of the English language and the appropriate comportment to represent UCB internationally at meetings and congresses.  

Discover more about UCB at www.ucb.com/careers.

UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system – or the central nervous system. With more than 8500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.  Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB. UCB and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer.  Minority/Female/Disability/Veteran

 


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