Working at Horizon Pharma is more than a job – it’s personal. We define success by a different set of numbers: the number of lives touched, the number of lives changed, the number of lives saved. 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 patients live up to theirs.
The Senior / Executive Director of Clinical Development will be responsible for overseeing internal and external activities associated with advancement of our rare and orphan portfolio. This person will play an active role on cross-functional program teams; this includes planning development strategies and interpreting data, as well as making hands-on contributions while managing vendors. The selected individual will be contribute to IND/NDA/CTA/ MAA submissions.
- Accountable for the design and execution of clinical development plan and clinical studies within that plan, working with a cross-functional team
- Represent the clinical development function on project development teams
- Identify relevant external experts and attain scientific and clinical insight for potential new indications
- Participate in scientific evaluation and due diligence activities as part of our active business development efforts
- Represent Horizon Pharma and the Clinical Development function at regulatory meetings, medical meetings, advisory boards, and other venues
- Participate in preparation of preclinical and clinical study protocol designs, preclinical and clinical study reports, and investigator brochures.
- Author high quality regulatory documents including INDs, CTAs and NDA filings.
- Maintains current awareness in area of expertise, prepares abstracts and manuscripts for scientific publications/presentations.
- Other duties as required
Qualifications and Skills Required:
- Masters or doctoral level (PhD, PharmD, MD,)
- Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem solving
- 10 years relevant industry experience, preferably with drug development
- Ability to provide strategic direction and guidance to teams aligned with clinical development plans
- Anticipates new trends in a competitive landscape and therapeutic areas to guide the organizational strategy
- Strong analytical skills with a data driven approach to planning, executing, and problem solving
- Effective communication skills to all levels of the organization
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Accomplished influencing and negotiation skills
- Ability to build successful and effective teams and collaborations internally as well as with external partners
- In depth knowledge of GCP and ICH
Horizon Pharma 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.