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Head of Clinical Operations

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:

  • Formulate the strategy for the Department in agreement with the CMO and the company strategy
  • Lead a team of internal- and external- multi-functional stakeholders focused on program management and study execution; evaluate and develop ideal outsourcing model for delivery on clinical portfolio, including selection and oversight of CROs and other vendors/ external partners.
  • Overall accountability for setting up, overseeing and directing all clinical operation activities, including biometrics and medical writing
  • Execute the strategy and other Department related tasks on time and with the expected quality
  • Maintain (and expand) the techniques/technology platforms to support the strategy
  • Plan, monitor and control the annual departmental budget and participate in quarterly budget reviews
  • Adhere to Orphazyme’s Quality Policy and in particular, write, maintain and approve department specific SOPs, and contribute to writing and maintaining other SOPs when relevant.
  • Secure adherence to Good Clinical Practice, current regulatory requirements and Orphazyme’s SOPs for relevant Department activities both internal and external
  • Ensure Assessment, selection, approval, oversight and final evaluation of vendors performing GXP activities within area of responsibility
  • Ensure good communication and information flow between the Department and other departments and project groups as well as stakeholder management
  • Establish and maintain contacts with external partners
  • Stimulate and maintain the scientific environment in the department
  • Vendor management and budget control
  • Role model the drug discovery and development model and the Orphazyme DNA, further strengthening Clinical Operations
  • Ensure Change Management – NDA readiness and organization complexity as Orphazyme moves their projects through the phases 

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.

Unique Human Capital A/S
T +45 7020 6700
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cvr: 31502705
Stamholmen 157
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8230 Aabyhøj
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+48 531 785 064
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01-211 Warszawa