A Career AT Orphazyme
Orphazyme is a development stage biopharmaceutical company. Our highly motivated and talented team of professionals is dedicated to the development of innovative therapeutic approaches to severe diseases, and cooperates with the research community worldwide.
Head Clinical Pharmacology
Reporting to the Chief Medical Officer and based in Copenhagen, Denmark, the Head of Clinical Pharmacology provides strategic leadership on all aspects of clinical pharmacology at Orphazyme.
- He or she serves as the clinical pharmacology lead on the clinical development programs providing strategic leadership and supporting execution of clinical development plans that include characterisation and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism of the drug candidate across all development stages.
- Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions.
- Provides extensive regulatory strategy expertise for regulatory interactions and drug filings and is responsible for Clinical Pharmacology sections of regulatory documents. Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent.
- He or she oversees and ensures constructive collaboration within external vendors / consultants to ensure high quality and timely execution
- Maintains extensive scientific awareness and presence in Clinical Pharmacology and engages with consultants and advisors in the field, as well as the scientific community
- Manages and mentors junior staff within the function as the organisation grows
- Strong leader with extensive experience in developing and executing Clinical Pharmacology Strategy and Development Plans
- Strong regulatory strategy expertise for drug filings and experience with Clinical Pharmacology sections of regulatory documents
- Demonstrated ability to work cross functionally to provide Clinical Pharmacology perspective & expertise across the organisation
- Strong English oral and written communication skills
- Employs a continuous improvement in knowledge and practical understanding of clinical pharmacology and pharmacometric principles and applies this knowledge in a program team setting.
- Education: PhD (preferably) in Pharmacy or equivalent and 8+ years relevant experience in clinical pharmacology
To apply send a CV and letter of application to contact@orphazyme,com