Clinical Program Director Neurology
il y a 4 jours
**Make your mark for patients.**
We’re here because we want to build the future and transform patients’ lives for the better. To achieve that, we need the brightest minds and biggest hearts. That’s why our Talent Acquisition Team looks for passionate people inside and outside the company. Are you interested in an internal move that will allow you to explore how much more you can do to make a difference for people living with severe disease?
To strengthen our Global **Clinical Development Team**, based in our **hub** in **Brussels**, **Belgium**, we are looking for a talented individual to fill the position of**:Associate Clinical Program Director or Clinical Program Director**.**
**As an Associate Clinical Program Director or Clinical Program Director you will be accountable for all clinical aspects of assigned Phase 2 - 4 program(s).**
In this role, you will work in an **environment **where you can:
- Be part of a great team who shares a collaborative spirit.
- Lead or contribute to the clinical team to ensure adequate design, planning, and implementation of the clinical development strategy including ownership of the Clinical Development Plan (CDP), the Investigator’s Brochure (IB) and of the Clinical Study Protocol(s) to enable:
- regulatory filing, approval and launch of NCEs/NBEs,
- regulatory approvals of new line extensions of registered compounds
You will **contribute** by:
- Leading or assisting in the development of the CDP ensuring alignment with UCB’s ambitions.
- Leading or assisting in the development of study concepts and study protocols, ensuring alignment with the CDP.
- Leading or assisting the clinical study team to achieve on-time delivery of assigned clinical studies within approved budgets and expected quality.
- Leading or contributing to the creation of the clinical components of regulatory submissions, including responsibility for on-time delivery of clinical components of regulatory submissions.
- Representing the company at meetings with Regulatory Authorities, partners, conferences, and advisory boards.
- For mature assets, providing clinical input during strategic discussions and life-cycle management opportunity reviews. This may include design or assessment of post-approval clinical studies such as non-interventional studies, registries, or other Real-World Evidence studies.
**Interested?** For this position you’ll need the following **education, experience** and **skills**:
- Master’s Degree required with a PharmD, PhD or MD preferred.
- 3+ years of relevant experience in biopharmaceutical clinical development is required, including the management of multiple clinical studies.
- Knowledge of relevant therapeutic area () with epilepsy or neurodegenerative experience.
- Experience supporting the development of submissions and presenting to regulatory authorities (e.g., FDA, EMA, PMDA).
- Demonstrated ability to think creatively and develop solutions with innovative study designs with consideration of real-world evidence a plus.
**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.
**About us.**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.
At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.
UCB is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protect by law.
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