Clinical Research Director

Company: Horizon Therapeutics
Location: Reston
Posted on: November 21, 2022

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.

Responsibilities:
Support clinical pharmacology function for clinical development of both small and large molecules and act as clinical pharmacology subject matter expert on multidisciplinary teams.
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 stakeholders.
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 disciplines.
5 years of industry or equivalent experience in PKPD, clinical pharmacology, and/or pharmacometrics (DMPK experience is a plus).
Proficiency in mathematical modeling and programming as demonstrated by hands-on experience in computational tools (e.g. R, NONMEM)
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.
Professional, proactive demeanor.

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.
Associated topics: biopharma, dietary, histology, histotechnologist, immunoassay, immunology, injury, medicine, microbiology, nephrology

Keywords: Horizon Therapeutics, Reston , Clinical Research Director, Executive , Reston, Virginia