Sr Clinical Pharmacologist

Employer
  • Horizon Therapeutics

Job Description

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.

Position Summary: Support clinical pharmacology and DMPK function from pre-IND to post approval for both small and large molecules in all therapeutic areas.

Responsibilities:

  • Support clinical pharmacology and DMPK function from pre-IND to post approval for both small and large molecules in all therapeutic areas.
  • Under the guidance of clinical pharmacology lead, collaborate with toxicologist and preclinical pharmacology scientists to design, analyze, interpret, 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.
  • Conduct non-compartmental and population PK, PK/PD, and exposure-response analysis to support study design and data interpretation of clinical pharmacology studies.
  • Present clinical pharmacology and DMPK results to internal and external stakeholders.
  • Contribute to author nonclinical, clinical and regulatory documents related to DMPK and clinical pharmacology components, including protocols, study reports, INDs, IBs, briefing documents for regulatory meetings, and NDA/BLA; author scientific publications.
  • Work closely with collaborators and CROs in study protocol/report review for both preclinical and clinical studies.


Qualifications and Skills Required:
  • ~3 years of industry or equivalent experience and an MD, PhD or PharmD degree in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, clinical pharmacology or other related disciplines
  • Experience in mathematical modeling and programming (e.g. R, NONMEM, Phoenix WinNonlin) is preferred
  • Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.
  • Self-directed and motivated researcher, with willingness to learn new tools and approaches.
  • Excellent written and verbal communication skills.


Horizon Core Values & Competencies:

Growth
  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Cultivates Innovation
  • Develops Talent


Accountability
  • Drives Results
  • Ensures Accountability
  • Decision Quality


Transparency
  • Courage
  • Collaboration
  • Instills Trust


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. more