Director, Clinical Pharmacology
Company: Horizon Therapeutics
Location: Waukegan
Posted on: May 21, 2023
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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. Position Summary The Director, Clinical
pharmacology and DMPK will be responsible for overseeing internal
and external activities supporting the preclinical DMPK and
clinical pharmacology of multiple programs in the corporate
portfolio. This person will play an active role on cross-functional
program teams; this includes planning development strategies and
interpreting data, as well as making hands-on contributions while
managing vendors. The selected individual will be responsible for
the DMPK and clinical pharmacology sections for IND/NDA (or
BLA)/CTA/MAA submissions. This person will interface closely with
various other functions to ensure timely cross-functional
information sharing of key DMPK and clinical pharmacology aspects
of the program. This position will also help with stage-appropriate
diligence evaluations of external opportunities Responsibilities
Manage a team of clinical pharmacologists Responsible for the
design and execution of clinical pharmacology strategy for multiple
programs Serve as a key source of scientific expertise for the
study design, analysis, reporting, and presentation of
pharmacokinetic (PK), PK/pharmacodynamic (PD), and
exposure-response data Prepare and implement strategic and
scientifically sophisticated DMPK and clinical pharmacology plans
for drug development that meet regulatory requirements and program
goals Responsible for the study design, analysis, interpretation,
and reporting of preclinical DMPK and clinical pharmacology data
Design and implement Model Informed Drug Development (MIDD)
strategy for various programs. Drive PK and PK/PD modeling support
to both preclinical and clinical project teams for key DMPK and
clinical pharmacology deliverables Support DMPK and clinical
pharmacology components of preclinical and clinical study design,
protocol development, data analysis and reporting Prepare verbal
and written summaries for internal discussions and author high
quality regulatory documents including IND/CTA/NDA/BLA/MAA filings
Represent clinical pharmacology in regulatory interactions (eg,
pre-IND, EOP2, pre-NDA/BLA) Participate in the management of CROs
and academic sites in the conduct of in vitro/in vivo DMPK studies
Partner with and support research, toxicology, bioanalytical
sciences, clinical development, regulatory, project management and
other departments Participate in external business development
Maintains current awareness in area of expertise, prepares
abstracts and manuscripts for scientific publications/presentations
Qualifications and Skills Required Ph.D. in Pharmacokinetics,
pharmacometrics, pharmaceutical sciences, DMPK or related
disciplines with thorough knowledge of clinical pharmacology, DMPK,
and pharmacometrics Minimum 6-8 years of pharmaceutical industry
experience including PKPD, clinical pharmacology, and/or
pharmacometrics (DMPK experience is a plus) Thorough understanding
of regulatory strategies and guidelines. Strong experience in
regulatory filings and interactions with regulatory authorities
worldwide Proficiency in mathematical modeling and programming as
demonstrated by hands-on experience in computational tools (e.g.
Phoenix WinNonlin, R, NONMEM) Leadership, project management
skills, and experience with managing external vendors Excellent
communication and interpersonal skills and the ability to
facilitate constructive, expedient problem solving Professional
demeanor Self-starter attitude Our Values Transparency: 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 employees Enterprise Mindset: Look beyond
one's team, brand or function to see the broader company and
external perspective Exhibit Intellectual Curiosity: Seek to
understand what you do not know; ask the right questions of the
right people and sources Ensure Accountability and Courage: Step up
to address difficult issues and hold self and others accountable to
commitments Embrace Diverse Perspectives: Welcome others with a
respectful attitude; integrate diverse perspectives into ways of
working Develop Talent: Provide feedback, coaching and mentorship
to help others be more effective in their role Our Values
Transparency: 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
employees Enterprise Mindset: Look beyond one's team, brand or
function to see the broader company and external perspective
Exhibit Intellectual Curiosity: Seek to understand what you do not
know; ask the right questions of the right people and sources
Ensure Accountability and Courage: Step up to address difficult
issues and hold self and others accountable to commitments Embrace
Diverse Perspectives: Welcome others with a respectful attitude;
integrate diverse perspectives into ways of working Develop Talent:
Provide feedback, coaching and mentorship to help others be more
effective in their role Compensation and Benefits Summary: The
salary range for this role is $202,500.00-$247,500.00 annually. The
base salary offered may vary based on the final candidate's
qualifications. The level of this role may also change based on the
final candidate's qualifications. In addition to the salary, this
position is eligible for the benefits listed here and for the
following plans: Salary Plan, Annual Merit Plan, Annual Equity
Grant, New Hire Equity Grant, Corporate Bonus At 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, Waukegan , Director, Clinical Pharmacology, Executive , Waukegan, Illinois
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