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

Director, Clinical Development

Location: 

Boston, Massachusetts, United States

Job Function:  Clinical Development
Job ID:  67901

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?

 

 

 

 

To strengthen our Clinical Development Team based in our Ra Pharmaceuticals division in Cambridge, MA we are looking for a talented individual to fill the position of Director of Clinical Development - Zilucoplan

 

As the Director of Clinical Development you will have oversight for the Phase 2 studies in IMNM and PNH Phase 1 clinical trials (TQT, hepatic impairment and two phase 1 studies with extended release formulations) and contribute to the filing of zilucoplan in myasthenia gravis. The role may expand into additional indications for zilucoplan or oversight of additional clinical trials.

 

You like to work in an environment where you can:

  • Serve as a scientific and clinical expert within a cross-functional team.
  • Have a significant role in collaborating with team responsible for all scientific aspects of the clinical trials.
  • Be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports investigator brochures, and development plans.
  • Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance, in collaboration with the medical monitoring team from the CRO.
  • Ensure adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
  • Coordinate the collection and analysis of clinical data for analysis and review.

 

You will contribute by:

  • Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.
  • May be asked to prepare presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
  • Develop manuscripts for publication in peer-reviewed journals.
  • Will be part of a team responsible for defending the clinical development program before regulatory authorities.

 

Interested? For this position you’ll need the following education, experience and skills:

 

Minimum Qualifications:

  • MD or MD PhD required; board certification preferred
  • Minimum of 3-5 years of  pharmaceutical industry clinical trial experience with a proven track record in clinical research studies and trial design.
  • Demonstrated understanding of Good Clinical Practices (GCP).

 

Preferred Qualifications:

  • A strong publication record is preferred
  • Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
  • Strong leadership skills with an ability to set vision, lead change, and mentor others.
  • Ability to proactively understand and analyze risks and take appropriate action before problems occur.
  • Willingness to lead by example, roll up the sleeves and get things done
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
  • Outstanding scientific written and oral communication skills.
  • Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
  • Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
  • Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings.

 

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

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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