Working at Horizon is more than a job – it’s personal. For us,
success is measured by the numbers that matter most – the number of
lives we touch, the number we change and those we work tirelessly
to help save. We’re a team of agile, out-of-the-box thinkers who
are inspired to do more because we know we’re a part of something
bigger. We strive to build meaningful careers at a company whose
values we share because when we live up to our potential, we help
others live up to theirs.
Member of Horizon´s clinical development teams, contributing to
the design, analysis and reporting of clinical studies. Activities
to include protocol writing, study conduct oversight according to
best practice and national and international guidelines and
regulations, as well as Horizon’s objectives and standard operating
Data analysis support and data interpretation with data
representation to internal and external (regulatory) audiences is a
core skill set requirement. Experience in collaboration with
statistics and clinical operations colleagues is required.
Work closely with the Therapeutic Head of Rare Disease VP role
to ensure robust protocols and appropriate study oversight.
Standing member of clinical trial and post marketing safety
review groups as well as the product development teams.
Provide input into and review key internal and external reports
such as Investigator Brochure, Risk Language, Informed Consent,
study Protocols, study operations manuals, etc.
Demonstrated ability to interact with study site investigators
regarding subject eligibility, dosing, safety and other clinical
trial conduct issues as needed.
Contribute as needed to key safety documents, in collaboration
with PSPV and regulatory colleagues including the PADER, PSUR,
Provide clinical-scientific input into the development of
Product Labels, core company data sheets (CCDS), Risk Evaluation
and Mitigation Strategy and Risk Management Plans.
Provide guidance to managers before, throughout, and following
clinical trials to ensure compliance for proper study conduct
throughout clinical trials
Review data from clinical trials, including ongoing review of
clinical trial safety data, laboratory data, ECGs, as required in
collaboration with PSPV colleagues; liaise with Safety Data
Monitoring Board, if applicable
Review of non-clinical data as required.
Review of clinical pharmacology data as required.
Review of post-marketing safety data as required to inform label
language and to support internal and external company reviews of
the product safety profile.
Participate in evaluation of life cycle management opportunities
including assessment of adjacent indications, assessment of
investigator initiated trial proposals, etc.
Support development of medical affairs materials, based on
clinical trial datasets.
Participate in due diligence activities as requested.
Education & Professional Experience
A degree in medicine with at least 3 years of
biotech/pharmaceutical experience in clinical development related
Demonstrated ability to work cross functionally in a matrixed
Horizon Core Values & Competencies:
Horizon Therapeutics plc does not discriminate on the basis of
race, color, religion, gender, sexual orientation, national origin,
age, disability, veteran status, or any other characteristic
protected by law. It is our intention that all qualified
applications are given equal opportunity and that selection
decisions be based on job-related factors. Any individual, who,
because of a disability, needs accommodation or assistance in
completing this application or at any time during the application
process, should contact the Human Resources Department.
Posted 30+ Days Ago
About Us Horizon is focused on researching, developing and
commercializing medicines that address critical needs for people
impacted by rare and rheumatic diseases. Our pipeline is
purposeful: we apply scientific expertise and courage to bring
clinically meaningful therapies to patients. We believe science and
compassion must work together to transform lives. For more
information on how we go to incredible lengths to impact lives,
please visit follow us @HorizonNews on Twitter,
like us on Facebook or explore career opportunities
on LinkedIn .
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