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Associate Medical Director

Company: Horizon Pharma
Location: South San Francisco
Posted on: June 8, 2021

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:

  • Member of Horizons clinical study team, contributing to the design, analysis and reporting of clinical studies. Activities include protocol writing, study conduct oversight according to best practice and national and international guidelines and regulations, as well as Horizon's objectives and standard operating procedures (SOPs).
  • Data analysis support and data interpretation and presentation, along with colleagues in statistics, PV-safety and regulatory affairs to the development teams. Experience in collaboration with statistics, safety and clinical operations is required.
  • Work closely with the Clinical Development team leader to ensure robust protocols and appropriate study oversight.
  • Standing member of clinical trial team and safety review groups.
  • Provide input into and review key internal and external reports such as Investigator Brochure, Risk Language, Informed Consent, study Protocols, study operations manuals, etc.
  • Demonstrated ability to interact with study site investigators regarding subject eligibility, dosing, safety and other clinical trial conduct issues as needed.
  • Contribute as needed to key safety documents, in collaboration with PSPV and regulatory colleagues including the PADER, PSUR, DSUR, etc.
  • Provide clinical-scientific input into key safety documents, as required.
  • Provide guidance to managers before, throughout, and following clinical trials to ensure compliance for proper study conduct throughout clinical trials
  • Review data from clinical trials, including ongoing review of clinical trial safety data, laboratory data, ECGs, as required in collaboration with PSPV colleagues; liaise with the clinical development team and if requested with the Horizon Safety Committees.
  • Review of non-clinical data as required.
  • Review of clinical pharmacology data as required.
  • Participate in evaluation of life cycle management opportunities including assessment of adjacent indications, assessment of investigator-initiated trial proposals, etc as requested.
  • Support development of medical affairs materials, based on clinical trial datasets.
  • Participate in due diligence activities as requested.
  • Support team with setting up investigator meetings and advisory boards with regards to presentation on clinical protocol or data to be communicated

Education & Professional Experience

  • A degree in medicine with residency training completed.
  • Demonstrated ability to work cross functionally in a matrixed environment.

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.

Keywords: Horizon Pharma, South San Francisco , Associate Medical Director, Other , South San Francisco, California

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