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Orphazyme is a very ambitious and visionary company. The company has had a good and well-paced growth during several years meaning that they are very much in control of their business and have well driven processes.
As Head of Clinical Operations at Orphazyme you will have the overall responsibility for the delivery of the clinical trial pipeline. You will be accountable for managing the clinical operations resources ensuring efficient and effective allocation enabling delivery of the trials.
The Head of Clinical Operations position is based in the Department of Clinical Development. The department is responsible for formulating, overseeing and directing clinical development activities, typically with the assistance of CROs. Reporting to the Chief Medical Officer, the Head of Clinical Operations will be accountable for Clinical Operations, including biometrics and medical writing.
Your focus areas are:
Your qualifications are at least 15 years of experience from the pharmaceutical industry, and line management experience from a similar position. You have experience with taking a drug from phase 1 and up to launch. You have experience with cross-functional business leadership and have scientific/medical/regulatory FDA (EMA) experience and insights. You have practical experience working at a CRO or in collaborating with CROs as well as solid knowledge and experience with GCP, ICH and relevant FDA/EMA regulations.
Preferably, you have a theoretical background within the life sciences or similar, and possibly a PhD.
You are a person with the ability to synthesize data from several sources and can formulate the essential text needed to convey clear and consistent messages to regulatory agencies and key stakeholders. You are a competent user of MS Office, Access and other relevant IT tools or systems. You have the ability to work with and synthesize data to support Risk Based Monitoring and oversight of clinical trials and clinical trial data in collaboration with other team members. You have a proven track record of leadership and management incl. delegation, sparring, coaching, feedback, prioritization, empowerment, development, structure and long-term planning. Finally, you are goal oriented, have strong oral and written communication skills, are good at motivating people, and are an excellent team-worker.
Orphazyme offers a unique opportunity to influence your own work as well as your personal and professional development. It is a position in a company in development with an exciting pipeline and a positive and informal environment.
Travelling: Approx. 30 days per year
Domicile: Central Copenhagen
For more details about the job, please contact Unique Human Capital, Partner Jørn Duhn on M.: +45 21 75 19 25. All applications must be in English and are treated confidentially.