Medical Director, Clinical Development
Company: Horizon Therapeutics
Location: Bethesda
Posted on: March 19, 2023
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Job Description:
Job Description:
At Horizon Therapeutics, we define success by the number of lives
touched, lives changed, and lives saved. Our global biotechnology
company is made up of agile, out-of-the-box thinkers with a focus
on delivering breakthrough medicines to those living with rare,
autoimmune, and severe inflammatory diseases. This is the heart of
our global mission. Start a career that enables you to live up to
your potential and help others live up to theirs. Join us. The
exceptional support we provide patients and communities equally
extends to our employees. We offer industry-leading and
award-winning benefits, compensation and rewards programs that
positively impact all areas of our employees' personal and
professional lives. Responsibilities:Member of Horizon's clinical
development team, leading and contributing to the design, analysis
and reporting of clinical studies. Activities to include protocol
writing, study conduct oversight including medical monitoring
according to best practice and national and international
guidelines and regulations, as well as Horizon's objectives and
standard operating procedures (SOPs).Data analysis 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.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, DSUR, etc.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 cross-functional colleagues
before, throughout, and following clinical trials to ensure
compliance for proper study conduct throughout clinical
trialsReview 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 applicableReview 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.Education & Professional ExperienceA degree in medicine
with at least 5 years of biotech/pharmaceutical experience in
clinical development related activities.Demonstrated ability to
work cross functionally in a matrixed environment.Our
ValuesTransparency: We value collaboration. Trusting teach other
and tackling tough challenges can make a powerful
difference.Accountability: We do what's right for our patient
communities through quality decisions and owning our successes and
failures.Growth: We fiercely innovate and evolve to better
ourselves, our communities and our patients.These three values come
to life through our five Leadership Expectations that apply to all
Horizon employeesEnterprise Mindset: Look beyond one's team, brand
or function to see the broader company and external
perspectiveExhibit Intellectual Curiosity: Seek to understand what
you do not know; ask the right questions of the right people and
sourcesEnsure Accountability and Courage: Step up to address
difficult issues and hold self and others accountable to
commitmentsEmbrace Diverse Perspectives: Welcome others with a
respectful attitude; integrate diverse perspectives into ways of
workingDevelop Talent: Provide feedback, coaching and mentorship to
help others be more effective in their roleAt Horizon, we know that
disease does not discriminate. We embrace the bold ideas of one
another, foster a sense of belonging, and value inclusion. We
attract and develop diverse talent because we believe that when
people from different backgrounds and life experiences come
together, we make lives better. Horizon intends that all qualified
applications are given equal opportunity, and that selection
decisions be based on job-related factors. We do not discriminate
based on race, color, religion, gender, sexual orientation,
national origin, age, disability, veteran status, or any other
characteristics protected by law.
Keywords: Horizon Therapeutics, Bethesda , Medical Director, Clinical Development, Executive , Bethesda, Maryland
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