The Role of Scientific Reseachers in Pharmaceutical R&D
Source: Clinical Discovery Magazine By Jim Loftus and Dr. Mark Edwards; January/February 2007
The road to a more effective, new medicine for use by patients is necessarily long, complex and fraught with pitfalls. For every 40 potential new drugs that show promise in vitro, only 1 or 2 ultimately become â€œapprovedâ€ medicines 10-15 years later. It is therefore not surprising that pharmaceutical companies demand the highest calibre scientists to work in their R&D groups. In this article, we describe the roles and the potential career development opportunities within pharmaceutical R&D for two types of researcher; the Research Biologist and the R&D Clinician.
The Research Biologist
Preclinical drug discovery and development offer numerous opportunities for well trained life scientists. For any drug it is important to establish that it works, is safe for patients to take, and what happens to it once itâ€™s administered. This is broadly the remit of Discovery Biology, Drug Safety R&D (DSRD) and Pharmacokinetics, Dynamics and Metabolism (PDM).* Entry to careers in these departments is possible at a number of levels, from school leaver to graduate to PhD, and at more senior levels. Although these departments will recruit biologists from a range of backgrounds (including Pharmacology, Physiology, Biochemistry and Molecular Biology), roles for Biomedical Scientists can be found in all departments working as part of multidisciplinary teams. Examples include histologists working in discovery programmes looking at tissue changes in disease models and the ability of experimental drugs to prevent these. In drug safety they look for drug related histopathology. Scientists with a clinical chemistry background have skills relevant to bioanalytical roles analysing pre-clinical and clinical samples for drug levels and therefore enabling pharmacokinetic profiles to be analysed. Their skills and knowledge are also useful in identifying and analysing potential efficacy and safety biomarkers, which is an area of great importance in modern drug discovery and development. Toxicology labs also have a requirement for trained pathologists to diagnose histological changes in preclinical toxicology.
For graduate entry level positions a usual requirement is a 2:1 honours degree with some practical experience. Occasionally vacancies will arise for experienced graduates with transferable skills and a flexible attitude. Factors affecting availability of these positions will be the structure of the individual company and where and how it does its research. Itâ€™s worth investigating websites of pharmaceutical companies and CROs (contract research organisations) to see what potential opportunities there are. If a lack of research or industrial experience hinders your job search, and you donâ€™t have the opportunity to pursue this in your current environment, one solution might be to find contract work through an agency, although there is no guarantee of permanent employment at the end of a contract.
Once employed by a pharmaceutical company your career path can take various directions. Flexibility is a key word â€“ my career took me from being a histologist (I trained in a hospital pathology laboratory) to carrying out in vitro biochemistry experiments looking at cellular metabolites, to research looking at whole animal disease models, and eventually out of the lab altogether into a training and recruitment role. Other people build their careers moving up the research ladder into roles of increasing scientific impact and responsibility. Others use their scientific training to move into any of a multitude of roles available in the pharmaceutical industry, including some of those described in the next section on clinical research.
*The names of departments with similar functions will vary from company to company. A search of individual websites is a useful way of orientating yourself to their structures and terminology.
The R&D Clinician
Clinicians working in pharmaceutical R&D usually have a medical degree with a postgraduate qualification (e.g. MRCP, MD, PhD) or a biomedical PhD with experience in clinical research. Clinical experience may be broad or highly specialised within a specific disease area.
Within the Clinical R&D department of a large company conducting research into many therapeutic areas, a clinician will gain a broad range of professional and research experience. Working within large multidisciplinary drug development teams, the central role of these â€œclinical researchâ€ doctors is to bring their clinical perspective to all research and development activities.
Before human clinical studies commence, the clinician must work with other research colleagues (e.g. Discovery Biology) to ensure that an appropriate level of prospective scientific thinking goes into understanding the clinical development strategy for an investigational drug. For example, is the unmet medical need fully understood i.e. which patients will potentially benefit from this new medicine? what does preclinical data suggest about the potential efficacy, tolerability and safety profiles in humans?; how will biomarkers be developed and validated?; how will theoretical, potential or actual risks be assessed and appropriately communicated? In essence, their role is to develop the clinical aspects of a â€œproduct profileâ€ to ensure all feasible clinical uses for the new drug have been considered. This maximises the potential benefit of the medicine to patients and society.
The clinical trial is the fundamental tool of clinical research and in collaboration with colleagues in other specialties the R&D clinician is responsible for their design. Clinical trials must be designed with the highest scientific rigour as they generate the data that underpin both internal decision-making as well as approval of a new medicine by regulatory agencies. The clinician is also responsible for understanding and communicating the emerging benefit-risk of a new medicine as it progresses through the stages of clinical development.
Hopefully this gives some flavour as to how varied the role of a research clinician may be. There are various career paths for an R&D clinician that will usually depend on an individualâ€™s area of interest. For example, someone with a good balance of technical and people-management skills could pursue either clinical team leadership or therapy area management opportunities. However, those whose interests remain more firmly centred in science and technology would probably have opportunities as senior â€œscientific advisersâ€. Alternatively their scientific expertise and background in â€œclinical applicationâ€ may be usefully transferred to other departments (e.g. Discovery).
The Medical Marketing group is often the beneficiary of clinicians with R&D experience, especially if that person has taken the drug through its development to regulatory approval. In this instance the R&D clinician often brings years of medical therapy area and drug knowledge that can readily be applied to the development of marketing strategies. They can understand the totality of the research results for a medicine and ensure that product strategy and marketing is supported by a good quality evidence base. Here, the clinician would also be responsible for product positioning via the review and approval of promotional materials, interactions with key opinion leaders, sales force training and the design, medical execution and interpretation of phase 4 clinical trial programmes.
Pharmacovigilance (drug safety) is another area where clinicians with R&D experience may find career development opportunities. The ongoing review of safety data throughout a clinical programme is fundamental to the identification, assessment and management of emerging safety signals, as is the timely and comprehensive regulatory reporting of serious adverse events. These data form a pivotal component of the clinical safety summaries that are submitted to regulators as part of their review and approval process for a new medicine.
Finally, possessing a clinical background can also provide complementary skills sets to departments that are not primarily clinically or medically focussed. As well as Discovery, other departments within pharmaceutical R&D where clinicians may find rewarding development opportunities include Regulatory Affairs, Clinical/Development Operations and Science Policy and Public Affairs. A career in this industry is varied and rarely dull. Clinicians work at the cutting edge of science - interpreting this and translating it into medicines that bring benefit to patients and society. Biology is unpredictable; the attrition in our industry is high. No two days are the same and problems are often those that have never been faced before. The intellectual challenge is great. The reward when a successful medicine reaches the patient is fantastic.
The research and development of new medicines in the pharmaceutical industry is a challenging and highly rewarding career option for research scientists. Pharmaceutical R&D requires scientists of the highest calibre and while specific skills sets are needed for some individual tasks, a successful outcome i.e. the delivery of a new therapy for patients, will only happen as a consequence of integrated working within a multidisciplinary development team over a lengthy period of time. Opportunities for career development are extremely varied and reflect the multiple skills needs that a successful R&D company must have. For an individual scientist, no career path should ever be thought to be impassable or closed.
Jim Loftus GIBiol, Discovery Recruitment Manager, Pfizer Global Research and Development, Sandwich Laboratories
Dr Mark Edwards BSc MB BS FRCA, Senior Director Science Policy, Pfizer Global Research and Development, Sandwich Laboratories