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

Clinical Program Director - Global Clinical Development

Location: 

Cambridge, Massachusetts, United States

Job Function:  Clinical Development
Job ID:  68366

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

 

 

 

 

We are seeking a Clinical Program Director (CPD) for our exciting late stage programs. As a CPD within UCB, you will be part of Global Clinical Development with accountabilities for a portfolio of assets. This role you will lead a clinical team composed of members from clinical operations, biostats, medical writing and representatives from the CRO. The Clinical Program Director is accountable for all clinical aspects of assigned programs, including creation of the clinical development plan and associated clinical study protocols; study oversight and data analysis. You are also a key interface with regulatory affairs, medical affairs, real world evidence and health economic and outcome research. Through your passion and leadership, you will bring innovative solutions to patients living with rare diseases.

 

As a Ra Pharmaceuticals -  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), 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 educationexperience and skills:

  • 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, rheumatology/immunology or hematology) 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 innovative solutions; experience with real world evidence a plus
  • Experience supporting the development of Regulatory 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
  • Goal oriented, driven individual wo whishes to team up with a group of enthusiastic, high performing indiviuals who can seamlessly transition between teamplayer and leading roles 
  • Intellectual curiosity and mental flexibility is key   
  • 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

 

 

 

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything 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 worldwide 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. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

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. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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