Clinical Program Director Drug / Device (US / RTP, NC) 1
Raleigh, NC 
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Posted 30 days ago
Job Description
JOB DESCRIPTION

Make your mark for patients.

We're here because we want to build the future and transform patients' lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what's possible?


To strengthen our Clinical Development Team, based in our RTP Office in Raleigh - Durham, NC, we are currently looking for a talented individual to fill the position of: Associate Clinical Program Director or Clinical Program Director Drug/Device.

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 (neurology) with epilepsy or neurodegenerative experience and Drug / Device.
  • 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.

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 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.

Curious to know more? Please visit our website .

Where permitted, applicants for employment in the United States must have received or be willing to receive a full COVID-19 vaccination by the date of hire; or, alternatively, agree to be subject to weekly COVID-19 testing, subject to religious and medical exemptions and in accordance with applicable law.

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.


UCB and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer. Minority/Female/Disability/Veteran

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Master's Degree
Required Experience
3+ years
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