Let's push the boundaries together and make the most of your
Location: Cambridge, Massachusetts, United States
Job Function: Clinical Development
Job ID: 69692
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
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.
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). The role may expand into additional
indications for 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
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
Develop manuscripts for publication in peer-reviewed
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:
MD or MD PhD required; board certification preferred
Minimum of 2-5 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).
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
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
Outstanding scientific written and oral communication
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
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.
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
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