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

Clinical Program Director/Associate Director

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Clinical Development
Job ID:  68491

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 Department, based either in Monheim (Germany), Brussels (Belgium), Slough (UK) or Raleigh (US) we are looking for a talented individual to fill the position of: Clinical Program Director

 

Please note, for this role, we are open to hiring someone at the Associate Director or Director Level.

 

As a ACPD/CPD, you will:

  • Be responsible and accountable for all clinical aspects of their assigned program(s)/missions
  • Provide leadership of the relevant clinical program(s) Phase 2 - 4.
  • Lead and ensure adequate planning, design, defense, and implementation of the clinical development strategy including generation and appropriate revision of the Clinical Development Plan (CDP), clinical aspects of the Target Patient Value Profile (TPVP), and the Investigators Brochure (IB) to enable:
    • Successful regulatory filing, approval and launch of NCEs/NBEs, additional regulatory approvals of new line extensions (indications or formulations) of registered compounds, prompt identification of safety or efficacy results that warrant re-evaluation of project plan and/or potential termination prior to registration.

 

You will contribute by:

  • Leading or contributing to the development and subsequent revisions of the CDP ensuring compatibility with the TPVP and representing contemporary research approaches.
  • Ensuring that study concepts and final protocols related to the relevant clinical development plans are of high quality, represent contemporary research approaches, are aligned with related CDP(s) and TPVP(s), and are appropriately managed by the clinical study teams.
  • Developing a strong knowledge base of the relevant disease area and therapeutics and becoming the company expert for the respective treatment modality.
  • Developing and maintaining 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 Program and Study Physicians, overseeing an ongoing evaluation of the benefit/risk ratio of the compound.
  • Contributing 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.
  • Leading or contributing to the planning and execution of high-quality clinical components of regulatory submissions for the indication(s)/formulation(s). Responsible for on-time delivery of clinical components of regulatory submissions.
  • Representing the company at meetings with Regulatory Authorities, partners, conferences, and advisory boards.
  • In conjunction with the Publications Team, serving as co-author and/or reviewer of scientific publications of results of clinical programs.

 

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

     Preferred Qualifications:

  • Master’s Degree required with a PharmD, PhD or MD preferred
  • Depending on previous professional experience, a minimum of 3 to 5 years of relevant experience in biopharmaceutical clinical development is required, including the management of multiple clinical studies
  • Experience in development and execution of pediatric plans preferred
  • Knowledge of relevant therapeutic area (neurology) with epilepsy experience preferred
  • Knowledge of clinical study designs that apply real world evidence (integrated patient databases such as claims and EMR) to clinical care is helpful
  • Demonstrated ability to think creatively and develop solutions using retrospective study designs with consideration of real world evidence a plus
  • Experience supporting the development of submissions and presenting to regulatory authorities (e.g., FDA, EMA, PMDA)
  • 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
  • Project management skills preferred.  Formal project management training a plus
  • Listening, coaching, mentoring, facilitation, influencing and negotiation skills
  • A participative management style
  • Ability to build effective team relationships with colleagues at all levels in the organization
  • Ability to work in a matrix type environment
  • Results oriented

 

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.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 

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. 

Apply now »