About the job
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.
- Will be responsible for delivery of development projects.
- Direct/Oversee the design and implementation of early stage clinical projects, as a member of our Product Development Team (PDT) and leader of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
- Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.
- Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan.
- Present and defend protocols and clinical development plans at internal governance forums.
- Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II/III studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations.
- Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
- Present study updates, interim results, and final headline data to senior management as required.
- Provide medical input and contribute to the clinical development sections of regulatory documents such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
- Ensure that Serious Adverse Events are properly reported on a global basis.
- Direct responsibility for leading a team of Clinical Development professionals and ensure delivery of their portfolio of assets.
- Implement clinical R&D policies, SOPs and related directives.
- Review potential in-licensing candidates and present recommendations to Senior Management groups.
- Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
- MD with a valid US medical license preferred; Thorough understanding of immunology and sub-specialty training in an area related immune mediated diseases (e.g. autoimmune diseases, neuroimmunology, transplantation) strongly preferred.
- Associate Director – 0-3 years’ experience in clinical research and/or drug development in CRO, pharmaceutical environment, or academia.
- Director – 3 – 5 years’ experience in clinical research and/or drug development in CRO, pharmaceutical environment, or academia.
- Good understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.
- Proficient in Microsoft Office.
- Professional, proactive demeanor.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.
Horizon Core Values & Competencies
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- 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.
- Hospital & Health Care
- Information Technology
- Total Years Experience 0-5
- Remote Work No remote work