Doctors play an important part in pioneering the next generation of medicines – supporting ground-breaking research into new treatments and ensuring the safety of volunteers and patients is paramount. Physicians working in the pharmaceutical industry will use their management and leadership skills, commercial awareness and ability to communicate effectively to influence the development of new medicines.

There are many areas where doctors play an important part within the pharmaceutical industry - either working in a pharmaceutical company or with a Contract Research Organisation (CRO). These include clinical development, healthcare marketing, regulatory affairs, drug safety (pharmacovigilance), clinical pharmacology, medical education, pharmaco-economics and epidemiology.

As well as providing medical support, doctors have a key role to play in clinical research.

Phase 1 clinical trials with healthy volunteers are undertaken in a carefully controlled setting. This may be within a clinical pharmacology unit linked to a hospital, or in stand-alone high quality facilities with full-time physicians, nurses and clinical support staff. Together they provide a safe, well co-ordinated environment to support innovative clinical development programmes. Trials start with very small doses of the medicine being given to volunteers to establish the pharmaco-kinetic and pharmaco-dynamic profiles of the compound. Based on the information derived at each stage, increasing doses are given until the expected therapeutic dose is reached.

The next stage of clinical trials involves fairly small numbers of patients who take part in trials designed to help establish the therapeutic effect and guide the dose and treatment regimen to be used in larger scale trials. For Phase 2 trials and the more extensive trials that follow, physicians will have a major role in developing the trial protocol, providing input into the analysis, interpreting and reporting trial results, as well as ensuring ethical compliance with standards. Physicians will work as part of a multi-disciplinary team and together decisions will be made on how further development should proceed.

Working in a pharmaceutical company or CRO gives doctors the chance to work at the frontier of medical knowledge and help develop the next generation of medicines. It is certainly exciting to be among the first to see new breakthroughs, but a balanced view of potential benefits is important as a major part of any doctor’s job is safety assessment. So, as well as monitoring improvements to patients’ health, the doctor must also be on the look out for adverse events.

Many doctors go on to specialise in areas such as pharmacovigilance and medical affairs, with companies keen to provide the training they need to develop the necessary expertise. Pharmacovigilance involves the assessment and monitoring of adverse events (side effects) of medicines in development and those already being prescribed.

Medical advisers work within Medical Affairs, providing a link between the company and key opinion leaders, preparing presentations for conferences and providing training for medical representatives. Medical advisers will provide medical input into the marketing strategy for the launch of a new product and for the promotion of existing products. They will ensure that promotional materials are compliant with the appropriate Code of Practice. In some companies and CROs, a Medical Adviser will also be involved in clinical research.

Physicians who work in Clinical Research

To join the pharmaceutical industry as a doctor, you must be registered with the General Medical Council and have completed at least two years’ general professional training following registration. Postgraduate qualifications, such as membership of a Royal College or PhD or MD will also be useful. Progression to senior roles usually requires further study such as an MSc in Pharmaceutical Medicine and/or the Diploma in Pharmaceutical Medicine awarded by the faculty of Pharmaceutical Medicine. Higher medical training is important for the ongoing professional development of physicians working in the industry.

For more information, please refer to:

Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians