Clinical development is the final stage of the development process and continues up to the approval of new products by the authorities. Clinical development departments are responsible for the planning, implementation, evaluation and quality of clinical trials and for international coordination. Your objective is to achieve the best possible approval for the worldwide introduction of new products and indications. Communication with government agencies on all regulatory and drug safety-related issues plays a key role.
Clinical Development and Registration is a complex, multidisciplinary activity that offers you, as a scientist, a wide range of interesting assignments:
Clinical Science: You will provide the scientific and medical expertise for the design of clinical development programmes and for the evaluation of patient safety aspects.
Clinical Operations: This is where most of the clinical monitoring and study management takes place. You will plan programmes that satisfy specific scientific requirements and implement them as efficiently as possible. The coordination of major international Phase III studies will place special demands on your organisational skills.
Drug Regulatory Affairs: You will interpret the requirements of health regulatory authorities and provide the skills needed to generate and present the requisite information to authorities, patients, buyers and prescribers. You will develop approval strategies, prepare new drug application dossiers and submit these for review.
Starting a career in Clinical Development
Your career will start in one of our Group companies as a clinical study monitor/clinical research associate working on a project assignment. You will support the Clinical Research department, which works closely with the marketing departments and is responsible for devising and performing clinical trials of our products in the local markets.
As a clinical study monitor you will monitor the investigating physicians during Phases I-IV of the studies. You will also work closely with the department's study managers to prepare the studies, make sure that they are conducted in accordance with Good Clinical Practice and coordinate all the corresponding activities. Your subsequent career path may lead you either into local marketing or global clinical development.
As a clinical science specialist in the global organisation you will work on one or more clinical studies in a team comprised of specialists of varying nationalities from different disciplines. Your primary tasks will be to prepare study designs, monitor the data entry process, conduct data reviews and evaluate the data in respect of efficacy parameters and adverse effects. You will summarise the course of the study in a study report and work with the documentation department to prepare the data for the drug approval dossier.
As a drug regulatory affairs manager you will be part of an international team of regulatory specialists. Under the direction of a global DRA manager you will be jointly responsible for all regulatory affairs issues relating to the development of products up until market launch and for all activities required to keep approved products on the market. As such you will also be involved in the development of global regulatory affairs strategies. You will communicate with others in the regulatory environment, coordinate applications and work together with the licensing authorities.
Your prospects in Clinical Development
Your experience in local Clinical Development will qualify you for global management tasks.
As a clinical study manager you will coordinate the planning and implementation of a global study programme in which trial programmes are performed in various countries according to specified criteria with the aim of collecting the data needed to obtain product approval.
As a global regulatory leader you will be responsible for coordinating the worldwide approval of new products and indications and will head up an international team.