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Associate Medical Director, Clinical Development

Company: Horizon Therapeutics
Location: Deerfield
Posted on: September 15, 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. Company: Horizon Therapeutics USA, Inc.Location: 1 Horizon Way, Deerfield, IL 60015Position Title: Associate Medical Director, Clinical Development Hours: Monday - Friday, 8:00 am to 5:00 pm 40 Hours/ WeekSummary of Duties: Must have knowledge of and experience with clinical study teams, contributing to the development design, analysis and reporting of pharmaceutical industry clinical studies. Must have knowledge of and experience with pharmaceutical industry global clinical trial management. Perform clinical trial protocol writing and study conduct oversight according to best practice and national and international guidelines and regulations, as well as study objectives and standard operating procedures (SOPs). Provide Data analysis support, data interpretation and presentation, working with member in statistics, Pharmacovigilance (PV)-safety and regulatory affairs, to the broader internal development teams. Use knowledge of and experience working in industry with statistics, safety and clinical operations. Work with the Clinical Development team leader to ensure protocols are developed and conducted with appropriate study oversight. Provide input into and review key internal and external reports, such as Investigator Brochures, Risk Language, Informed Consents, Study Protocols, and study operations manuals. Work with study site investigators regarding subject eligibility, dosing, safety and other clinical trial conduct issues as needed. Use knowledge and experience with key safety documents, in collaboration with PSPV and regulatory colleagues, for example the PADER, PSUR, DSUR, etc. Provide guidance to managers before, throughout, and following clinical trials to ensure compliance for proper study conduct. Review data from clinical trials, including ongoing review of clinical trial safety data, laboratory data, electrocardiograms, as required in collaboration with Patient safety and pharmacovigilance (PSPV) colleagues; liaise with the broader clinical development team and if requested with Safety Committees. Review non-clinical data and clinical pharmacology data as required. Evaluate life cycle management opportunities including assessment of adjacent indications, assessment of investigator-initiated trial proposals as requested. Support development of medical affairs materials, based on clinical trial datasets. Use knowledge and experience with the following: Drug development; developing clinical trial design concepts; protocol writing; Good Clinical Practice (GCP) and International Conference on Harmonization (ICH); and work cross functionally in a matrixed environment. Qualifications: Position requires a Doctor of Medicine degree, M.D., or an equivalent degree and 3 years of experience in job offered or 3 years of experience with clinical or basic research and/or drug development in CRO, pharmaceutical environment, or academia.Position requires 3 years of experience with the following: managing global clinical trials and clinical study protocol; contributing to the design, analysis, and reporting of pharmaceutical industry clinical studies; Good Clinical Practice (GCP) and International Conference on Harmonization (ICH); Study monitoring as per SOP, protocol, ICH GCP and US FDA guidelines; Development and review of study related documents including protocol, informed consent forms (ICF), standard operation procedure (SOP), product manuals, training materials and clinical studies reports; Electronic Data Capture (EDC) management and maintenance; Case Report Form (CRF) design and data listing; Position requires experience with the following: clinical supporting the development of therapeutic solutions; Trial Master File (TMF) management, vendor management, CRO management; and Evaluating and reporting Adverse event / Serious event (AE/SAE).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 requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law. 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.

Keywords: Horizon Therapeutics, Arlington Heights , Associate Medical Director, Clinical Development, Executive , Deerfield, Illinois

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