Psychiatrists entering the pharmaceutical industry in the UK

As a junior doctor, it can be extremely difficult to imagine a working life outside the NHS. Appointment to a consultant post brings some opportunity to practise medicine outside the NHS, but few contemplate a move to an entirely commercial setting. Those of us who have moved to work entirely in a commercial setting, as pharmaceutical physicians, tend to be regarded with a mixture of curiosity and suspicion by our peers and colleagues, who often reveal a great number of misconceptions about our roles and responsibilities. Yet, currently some 731 physicians are registered with the British Association of Pharmaceutical Physicians, with 25 recording psychiatry or neuroscience as their area of expertise. There are 1400 physicians registered on the mailing list for the Faculty of Pharmaceutical Physicians. It was through reflecting on the level of interest as to our motives and rewards that we were moved to write this article. To colleagues in the NHS, it can seem as if we have moved into an unknown and suspect world. This article aims to describe something of the role of the pharmaceutical physician and the initial experience of moving into the industry.

The recruitment process

New learning begins with the recruitment process. Pharmaceutical physician ‘entry level’ posts are usually advertised in the medical press, through recruitment agencies acting on behalf of client companies. They are interested in your candidature because their business depends upon it. Their interest extends to making the initial assessment of your suitability as an applicant, helping with curriculum vitae design and interview preparation. They need to get it right. A successfully-placed candidate can bring them up to 30% of the first year's salary. A failed placement can cost them their reputation.

The interview process with the company is often staged over several meetings with key individuals. Structured tools aid feedback meetings, where the strengths and weaknesses of the candidate are discussed and recorded. When an offer is made there is some room for negotiation regarding the terms and conditions of employment, but most of this discussion regarding the financial package will have been done through the recruitment agency.

Different companies deploy their physicians in different ways and the roles come described by a range of titles that are company-specific. One company's Clinical Research Physician may be another company's Medical Adviser. In general terms, mid- to large-sized pharmaceutical companies have a range of functions that have a legal requirement for physician sign-off. These functions include clinical research, marketing, regulatory affairs and pharmaco-vigilance.

In some companies, a physician may be employed to work within one specific functional area such as marketing support, pharmaco-vigilance or clinical research. In other organisations, the physician has a cross-functional role, requiring involvement in the activities of a number of different areas. Wherever he/she works within the company, the physician is uniquely positioned as an ethical guardian of medical and research practice within the company, accountable to the General Medical Council in the UK.

Clinical research

Clinical research is often the pull that encourages a physician to move into industry. Drug development involves drug discovery, followed by pre-clinical and clinical phases (healthy volunteer studies and early proof of concept studies, moving through to large-scale studies in patients prior to granting of a marketing authorisation and the conduct of post-marketing surveillance). Physicians may be recruited by pharmaceutical companies to work within any of these phases of development.

The pharmaceutical physician has an important part to play in many clinical research activities. Specific activities will, to a certain extent, depend on the phase of development, but typically the physician will play a major role in the writing of study protocols and/or reviewing protocols written by colleagues. Company physicians will often seek guidance from external experts in order to ensure that a protocol will be workable in practice. For this reason, there is an onus on the individual to know the subject area and the local clinicians well enough to take their advice at the various stages of protocol development and to predict their likely success in meeting the objectives for the study. In practical terms, this involves the research physician attending academic meetings nationally and internationally, and communicating by telephone and email with clinicians and academics who have research interests in common with the company. There is a need to visit clinical units and meet potential investigators and their teams so as to understand local issues that may promote or hinder success.

In addition to having a workable protocol, the industry physician is closely involved in the process of assessing investigator and site suitability. The research process is highly regulated as set out in the International Conference on Harmonisation - Good Clinical Practice Guidelines (ICH, 1995-2000). The aim of the Guidelines is to harmonise standards in clinical research internationally and establish the highest standards of clinical research practice. The implementation of clinical trials requires dedicated company resources in the form of money, study drugs and people to monitor the trial and assure its quality. The clinical research associate and clinical trial monitor perform the latter function, ensuring that the investigator and other site staff are collecting the data and submitting it in an ethical and accurate way. They are required to report protocol violations, adverse events and drug reactions. The physician supports the clinical research associate who, while expert in study methods and often possessing a higher research degree, will not always have the subject matter expertise. Together, the physician and clinical research associate train the investigator and other site staff on the study protocol, International Conference on Harmonisation - Good Clinical Practice Guidelines requirements and the compound under study. Additionally, the physician has the crucial responsibility of ensuring that those conducting the study have been thoroughly trained in the use of diagnostic instruments and rating scales required by the protocol.

The research physician supports the investigators, addressing queries about the study drug and reviewing reports of adverse events. These are sent to their colleagues in pharmaco-vigilance for recording and analysis. The research physician has a critical role in supporting the relationship with the investigator in times of difficulty. The study may fail to recruit the number of patients planned or may be stopped for other reasons, including concerns for patient safety.

Marketing support

Marketing support perhaps has most appeal for those physicians seeking a business or commercial career future. The production of ‘copy material’, mentioning a pharmaceutical product for use in humans, is strictly regulated by the Association of the British Pharmaceutical Industry (ABPI) Code of Practice ABPI, 2001. The pharmaceutical physician requires early training in the use of the Code. The system operates to self-regulate good practice. Awareness of the spirit and content of the Code enables the company physician to support the production of quality advertising and other marketing materials, and in addition facilitates scrutiny of the output of competitors and challenge where there are evident breaches of the code. In some instances this takes the form of physician-to-physician discussion. Where agreement cannot be reached, the Prescription Medicines Code of Practice Authority is asked to adjudicate. Their decisions carry with them financial and other penalties for companies found to be at fault. The physician may spend some considerable time compiling the evidence to make or rebut challenges of this type and negotiating with various parties involved. The code extends to the content and location of academic meetings, television and video and, more recently, the Internet.

In many companies, the physician has an important role to play in helping to shape marketing strategy and direction. The marketing team are experts in business, but usually lack experience of working with patients in the health care system. The physician is able to provide an invaluable ‘real world’ perspective to assist in the construction of ethical and appropriate marketing plans.

In addition to helping shape marketing strategy and ensuring that promotional materials comply with the Code of Practice, a third area where the physician may interact with their sales and marketing colleagues is in the training of salespeople. Ensuring that sales representatives, who constitute the ‘public face’ of a company, are knowledgeable in their therapeutic area, well-briefed and able to conduct their business in an appropriate fashion is obviously essential.

To meet the expectations of the marketing team and allow the sharing of clinical trial data, the physician will make presentations of data to internal audiences and external customer groups. This can involve a considerable amount of travel to support regional and local meetings, as well as national and international advisory boards. Advisory boards are conducted regularly to draw on the experience of subject matter experts, and national and international opinion leaders, who can steer the development of the research objectives for a compound or inform the marketing plan. The company physician can have a key role in selecting and inviting appropriate people to address the issues at hand.

As well as interactions with the marketing department, the physician may also find themselves supporting the activities of legal affairs, corporate affairs, regulatory affairs, health outcomes, market research and other departments at various times. For the physician moving from the NHS, many of these functions will be new. In many companies, there is ample opportunity for training in media handling skills, negotiation and communication skills, financial planning and budgeting. In turn, the physician may share their medical knowledge and experience with colleagues in other functional areas.

What skills are required?

It is almost impossible to describe a typical week in the life of a pharmaceutical physician, such is the variety of the demands on time and the continuing revision of priorities. Skills in personal and group management, time management priority setting and problem solving are prerequisites for managing the constantly-changing scene. The first contrast with clinical practice is that for the most part there are no patients, although some companies will support a continuing clinical session once a week. Nevertheless, the demands of colleagues working to tight deadlines and agreed plans more than makes up for this, and the atmosphere is in many ways more urgent and pressured in its intensity than that in clinical psychiatry.

A typical day in the office can begin with coffee and conversation, but quickly moves into large volumes of e-mail and voice mail to be reviewed, sorted and prioritised. There are electronic diaries that are filled and changed, double- or often treble-booked. Meetings occur throughout the day, one-to-ones, small groups, some by phone or video-conference. Working lunches are not uncommon and meetings can last from a few minutes to all day. Travelling time and arrangements have to be considered, there are expense claims to process, quality assurance measures to complete, and performance plans to review and revise. The time plan for the 3 months ahead is almost invariably filled and as new priorities emerge there is a need to renegotiate previous commitments, both to internal and external ‘customers’. Some of this work can be delegated or shared, and effective administrative assistants are on hand to help.

Days spent out of the office meeting clinicians or industry colleagues are no less pressured. The office still requires the physician's input, and the need to access email and voice mail from mobile phones calls for a working style that can accommodate communication from just about anywhere. Workspace in airport lounges and railway stations and hands-free mobile phone sets in the car become necessities rather than luxuries. Work time needs to be flexible, particularly in global organisations, as the physician may need to take part in global meetings across the 24-hour business day. Travel from time-to-time can encroach on weekends and evenings, which can challenge a healthy work-life balance.

From an entry level position in a mid-to large-sized global pharmaceutical company, there opens up a range of career opportunities. These can be looked upon in a number of ways. On the one hand, there are routes for technical experts in science, therapeutic areas, regulatory areas or pharmaco-vigilance. On the other hand, there are routes for those interested in the commercial side of the business. Both require leadership and management skills. For the technical expert, skills in individual and project management are needed. For the commercial physician, it will be skills in managing people and groups. These skills can be obtained through time spent in a variety of posts in each of the relevant medical areas, supplemented on the commercial route by time spent in sales and marketing or corporate affairs. In-work experience is complemented by a personal development plan, incorporating courses appropriate to the learning need. The plans are worked on in a climate of managed supervision, in the context of a performance review structure.

Career progress in the pharmaceutical industry depends on achieving well-defined goals, and may be to more senior roles within a national organisation, or to European or even global roles. The former are very senior business roles and inevitably carry with them responsibility for large numbers of people, large budgets and large problems faced by the company. The latter are very senior medical/scientific roles and may carry responsibility for in-house prioritisation of major research projects, design and implementation of international clinical trials and presentation of data to European or American licensing authorities.

The difference in the style and content of remuneration between the NHS and industry is noteworthy. Most companies currently offer a package of benefits. These include basic salary, health and life insurance, a company car and pension scheme. In addition, there are various ways in which strong performance can be rewarded through individual and company bonuses. Long service is encouraged and rewarded by investment options that mature after set periods.

It can be difficult for the aspiring pharmaceutical physician to understand the variety of options and benefits that exist within industry. In addition to discussion with friends and colleagues who have made the transition, it is important to discuss options with reputable recruitment agencies and to approach companies directly. Informal visits and career discussions allow the potential entrant to see the working environment and meet the people they would be working with. It is only by doing this that they can come to have a sense of what their working day might be like. For those of us who have crossed the divide, it can be a hugely rewarding experience. The options for career development and training are enviable and the people one works with tend on the whole to be dynamic and enthusiastic. In summary, work is always demanding, occasionally terrifying or frustrating, but never boring.

Declaration of interest

The authors are employees of Eli Lilly & Company, which employs psychiatrists as Clinical Research Physicians.