Executive Medical Director

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.

Position Summary: The Executive Medical Director within Clinical Development will be involved with the full scope of the rheumatology, autoimmune or rare clinical drug development activities from discovery research through first in human, POC and Phase 3 or Phase 4 studies. The role will include co-leadership of one or more assets within the portfolio and require people management activities. The position must work closely with all members of the cross-functional asset team, to apply full clinical knowledge to successfully advance clinical programs as well as the overall asset strategy

Responsibilities:

• Co-lead the asset team strategy with an enterprise mindset
• Manage clinical development medical or scientific directors who are managing various clinical trials for the asset

• Provide adequate oversight and mentoring of R&D personnel to design asset development plans and protocols spanning all phases of development per indication in collaboration with Horizon asset team members, key opinion leaders (KOLs) and CROs that are aligned with the target product profile
• Provide adequate oversight in the development of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis plan, and clinical study reports (CSRs) along with biostatistics and other R&D colleagues
• Drive clinical development components in the writing and data interpretation of CSRs
• Review, interpret and present asset data to internal and external stakeholders
• Provide adequate oversight and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents
• Contribute to publication strategy and content of individual publications, abstracts, and presentations
• Maintain up-to-date knowledge of scientific and clinical published literature
• Interact with KOLs to assure implementation of latest clinical thinking and guidelines into the integrated asset development plan
• Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, and consultants
• Provide input/review study start up documentations, e.g., CRF design
• Attend and provide clinical support for investigator and steering committee meetings
• Participate in due diligence and business development activities as needed
• Always operate within Compliance Guidelines
• Provide medical monitoring oversight for clinical trials as required

Qualifications and Skills Required:

• MD, DO or MD/PhD
• Technical skills: 10 or more years in biopharmaceutical sponsored clinical research is desirable
• Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable.
• Solid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approaches
• Ability to analyze and interpret complex datasets
• Exercises initiative in meeting goals and drives innovation in projects
• Proficient in Microsoft Office.
• Professional, proactive demeanor.
• Strong interpersonal skills.
• Excellent written and verbal communication skills.

Non-standard work schedule, Travel or environment requirements

• Occasional travel 10-25%

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.