Director, Clinical Pharmacology
Company: Horizon Therapeutics
Location: Vernon Hills
Posted on: May 22, 2023
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, Arlington Heights , Director, Clinical Pharmacology, Executive , Vernon Hills, Illinois
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