Medical Director, Rare Disease

Location
Brisbane, CA, United States
Posted
Oct 13, 2019
Ref
R0000949
Discipline
Science/R&D, Pathology
Required Education
Bachelors Degree
Position Type
Full time
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 Horizon's clinical development teams, contributing to the design, analysis and reporting of clinical studies. Activities to 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 with data representation to internal and external (regulatory) audiences is a core skill set requirement. Experience in collaboration with statistics and clinical operations colleagues is required.
• Work closely with the Therapeutic Head of Rare Disease VP role to ensure robust protocols and appropriate study oversight.
• Standing member of clinical trial and post marketing safety review groups as well as the product development teams.
• 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 the development of Product Labels, core company data sheets (CCDS), Risk Evaluation and Mitigation Strategy and Risk Management Plans.
• 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 Safety Data Monitoring Board, if applicable
• Review of non-clinical data as required.
• Review of clinical pharmacology data as required.
• Review of post-marketing safety data as required to inform label language and to support internal and external company reviews of the product safety profile.
• Participate in evaluation of life cycle management opportunities including assessment of adjacent indications, assessment of investigator initiated trial proposals, etc.
• Support development of medical affairs materials, based on clinical trial datasets.
• Participate in due diligence activities as requested.

Education & Professional Experience
• A degree in medicine (M.D.) with at least 3 years of biotech/pharmaceutical experience in clinical development related activities.
• 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.