Xintela is looking for a Director of Clinical Development to lead the execution of our clinical development programs through regulatory approval. The position reports to the CEO and will form part of the company’s senior management team. The incumbent will work in close collaboration with the various different functions in the company including R&D, Manufacturing and Business Development as well as with our external partners and service providers.
The Director of Clinical Development will be responsible for the design, planning and execution of all clinical development from late preclinical phase through to a marketing approval.
We are looking for an applicant with several years of demonstrable experience within clinical research in the pharmaceutical or biotech industry, and with experience working at or together with CROs. The Director, Clinical Development needs to have experience in all parts of the clinical trial process, from protocol development, site and study approval & activation, conduct of the studies, safety reporting and completion of all study reports. The person will also need to show expertise in managing external consultants including CROs and regulatory consultants to support the programmes. It is also important to have experience of working with clinical trials on a global scale.
The person needs to be highly motivated, organized and structured, with an ability to prioritize. It is important to be able to work independently and take self-directed decisions that deliver results. It is also important to be able to cooperate and work in teams. A good communicator, good presentation skills, positive with high energy and passion are other important competencies for this role.
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