Clinical Program Director TA Bone/NewMeds

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Date: Oct 14, 2018

Location: Monheim, DE

Clinical Program Director (Bone/New Meds)
Global Clinical Development and Medical Affairs
June 20, 2018

 Location: Raleigh, US; Monheim, Germany; Slough, UK or Brussels, Belgium

 

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 Clinical Development Practice, based in our UCB sites in Raleigh, US or, Monheim, Germany, Slough, UK or Brussels, Belgium (Headquarters), we are looking to fill the position of: Clinical Program Director (Therapeutic Area Bone / New Meds).


As a UCB Clinical Program Director you like to work in an environment where you can:

 

  • 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), pediatric plans,  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 the development and subsequent revisions of the CDP ensuring compatibility with the TPVP and representing contemporary research approaches.
  • Ensuring that study concepts, Protocol Summaries 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 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 the team in 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:

 

  • Master’s Degree required with a PharmD, PhD or MD preferred
  • Depending on previous professional experience, a minimum of 5 years of experience in biopharmaceutical clinical development is required, including the management of multiple clinical studies.
  • Experience in clinical development in rare diseases preferred
  • Experience in development and execution of pediatric plans preferred
  • 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 required.  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.

 

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 7500 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. 


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