Senior Clinical Program Director TA Bone/NewMeds
Date: Feb 13, 2018
Location: Anderlecht, BE
(Senior) Clinical Program Director
Patient Value Unit New Medicines
February 13, 2018 * Location: 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 Team NewMeds, based in our headquarter in Brussels, Belgium, we are looking to fill the position of: (Senior) Clinical Program Director.
Are you a conclusive person that knows how to influence others? This makes you a 'concluencer' at UCB. This innovative blend of talent means you can practice decisive sway over others to make change happen for patients.
As a UCB 'concluencer' and (Senior) 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, defence, 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.
As a UCB 'concluencer' and (Senior) Clinical Program Director you will contribute by:
* 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.
* Developing a strong knowledge base of the relevant disease area and therapeutics, and becomes the company expert for the respective treatment modality.
* 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.
* Contributing to the ongoing safety evaluation of a product with review of and/or contributions to aggregate reports.
* In conjunction with the Publications Team, serving as co-author and/or reviewer of scientific publications of results of clinical programs.
* Contributing to the product development strategy by leading the development and subsequent revisions of the CDP ensuring compatibility with the TPVP and representing contemporary research approaches.
* In conjunction with the Program Physicians, oversees an ongoing evaluation of the benefit/risk ratio of the compound.
* 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 and partners, if applicable.
Interested? For this position you'll need the following education, experience and skills:
* Master's Degree 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.
* Broad experience in writing and/or participation in the preparation of submission documents
* Experience in critical review of relevant development and regulatory documents outside the clinical arena required
* Current knowledge of all aspects of the global clinical development processes. Understands and applies scientific principles to trial design as well as data acquisition, analyses, and reporting. Applies fair balance in data interpretation.
* Previously led a clinical program through phase 3, submission, and regulatory approval processes.
* Demonstrates clear and articulate verbal, written and presentation skills
* Listening, coaching, mentoring, facilitation, influencing and negotiation skills.
* Ability to build effective team relationships with colleagues at all levels in the organization.
Have we made you curious?
Then we look forward to receiving your online application (please only use our online application tool) for this position stating your earliest availability or actual notice period as well as salary expectations. We thank you for your interest in UCB and look forward to get in touch with you! UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7700 people in approximately 40 countries, we generated revenue of EUR 4.2 billion in 2016.
Do you want to find out more about us then visit our website: www.ucb.com
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