Associate Director, Preclinical Pharmacology
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.
- Provides guidance on the design, execution and interpretation of preclinical R&D as well as collaborations to understand disease biology and mechanism of action. Scientific expert who contributes to responses to questions from regulatory agency on disease biology, mechanism of actions and immunogenicity. This may be achieved as an individual contributor or by collaborating with different disciplines and across cross functional teams
- Makes significant contributions to multidisciplinary, bioanalytical, regulatory and clinical team meetings
- Projects company leadership in R&D by interacting with industry opinion leaders. Leads effortst o generate and interpret data and communicate results internally and externally.
- Builds strong relationships and networks externally as well as internally with therapeutic area leaders, facilitating strategic alignment and collaborations with partners
- Detects, recognizes and communicates trends/events outside Company that could affect the direction of a therapeutic area/technology. Provides a long-term perspective on the direction of the therapeutic area/technology
- Maintains accurate and complete safety records consistent with company policy and legal requirements. Recognizes potential safety problems and takes action to rectify them
- Responsible for analyzing and interpreting data from preclinical and clinical studies
- Involved in planning experimental design and execution of all aspects of preclinical R&D including, in vitro assays, cell based assay, in vivo and ex vivo models of disease. Creative problem solving
- Provides oversight and works closely with collaborators and CROs in study protocol/report review, method transfer, compound and biological sample shipment and storage
Qualifications and Skills Required:
- PhD or equivalent experience in nucleic acid chemistry/chemistry/Biochemistry/analytical sciences or related field
- 10+ years in the biopharmaceutical industry
- 5+ years managing CROs
- Disease expertise in immunology related field is highly desirable.
- Specific expertise in preclinical R&D, in vivo and ex vivo model systems, PK, ADA, and clinical development. Hands-on experience with in vitro, ex vivo, in vivo, cell culture, and bioassays are highly desirable
- Demonstrated experience leading R&D strategies and execution
- Knowledge of assay development and validation, and understanding GLP requirements and ICH guidelines desirable
- Authoring reports/presentations/communication bullet
- Experience within a fast pace small biotech environment
- Proficient in Microsoft Office
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.