Associate Director, Clinical Pharmacology
Company: Horizon Therapeutics
Posted on: September 15, 2019
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.The successful candidate will support
clinical pharmacology function for clinical development of both
small and large molecules and act as clinical pharmacology subject
matter expert on multidisciplinary teams.Responsibilities:
- Responsible for study design and data interpretation of
clinical pharmacology studies, including pharmacokinetics,
pharmacodynamics, food effect, relative bioavailability, drug-drug
interaction, QTc, and special population studies.
- Conduct non-compartmental and population PK, PK/PD, and
exposure-response analysis to support key program decision-making
(eg, phase 2/3 dose selection).
- Author clinical and regulatory documents related to clinical
pharmacology components, including protocols, investigator
brochures, study reports, briefing documents for regulatory
meetings, and NDA/BLA; author scientific publications.
- Represent clinical pharmacology in regulatory interactions (eg,
pre-IND, EOP2, pre-NDA/BLA).
- Present scientific results to internal and external
- Collaborate with toxicologist and preclinical pharmacology
scientists to design, conduct, and report preclinical PK and
translational PK/PD studies to support candidate selection and IND
filing, including human PK prediction to support starting dose and
dose escalation schemes for first-in-man studies.
- Provide oversight and work closely with collaborators and CROs
in study protocol/report review for both preclinical and clinical
studies.Qualifications and Skills Required:
- PhD or equivalent experience in Pharmacokinetics,
Pharmacometrics, Pharmaceutical Sciences, or other related
- -5 years of industry or equivalent experience in PKPD, clinical
pharmacology, and/or pharmacometrics (DMPK experience is a
- Proficiency in mathematical modeling and programming as
demonstrated by hands-on experience in computational tools (e.g. R,
- Demonstrated ability to work in a highly collaborative,
multi-disciplinary team setting.
- Excellent verbal and written communication skills.
- Self-directed and highly-motivated researcher, with willingness
to learn new tools and approaches.Horizon Core Values &
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops TalentAccountability
- Drives Results
- Ensures Accountability
- Decision QualityTransparency
- Instills TrustHorizon 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
Keywords: Horizon Therapeutics, San Francisco , Associate Director, Clinical Pharmacology, Executive , Brisbane, California
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