The pharmaceutical industry employs thousands of doctors worldwide and is responsible for ground-breaking research which delivers innovative medicines to millions of patients. This research is conducted both within pharmaceutical companies and through close collaboration with research institutes and universities.
The discipline of Pharmaceutical Medicine focuses on how therapies can be used optimally in clinical practice. It involves providing medical and scientific support to the clinical research, medical information, pharmacovigilance, regulatory, health economics, and sales and marketing functions of a pharmaceutical company.
In this article I’ll provide an overview of the day-to-day activities of a doctor working for a pharmaceutical company.
Doctors choose to enter the pharmaceutical industry for several reasons:
Firstly, they may have been involved in clinical trials in the hospitals and enjoy the excitement of early phase drug development work. Joining the industry provides the opportunity to have more input into the direction of clinical trial programmes and more input into global research protocols.
They may also be seeking a more business-focused career. They may already have completed a business degree or had exposure to a commercial enterprise and are now seeking to extend this by developing a corporate career. Doctors bring an in-depth understanding of medical practice to the business aspects of the pharmaceutical industry and can therefore contribute to strategic decisions regarding which products to develop and how best to structure patient-focused initiatives.
All activities within a pharmaceutical company are ultimately for the benefit of the end-user, the patient. Doctors working within the pharmaceutical industry make a unique contribution through their understanding of hands-on patient management.
Medical Advisers will provide clinical input into all phases of drug development. They will be involved in initial feasibility discussions with hospital clinical trial investigators to discuss available patient populations and the relevance of proposed trial inclusion/exclusion criteria. With a practical understanding of how patients are treated in the Australian healthcare setting they can advise on protocol design and the optimal collection of data in Case Report Forms. In writing Informed Consent documents Medical Advisers have the bedside experience to translate complex topics into layperson’s language; and they can answer medically related questions from specialists on the Ethics Committee.
Prior to a clinical trial starting Medical Advisers will present material at an Investigator’s meeting and discuss the medical management of patients. Once a clinical trial has started the Medical Adviser can accompany the Clinical Research Associate on a monitoring visit and discuss overall trial management with the Investigator. When focusing on patient recruitment the Medical Adviser can use their practical understanding of patient behaviour to suggest strategies to improve recruitment and retention.
During the trial the Medical Adviser is available to discuss any patient related enquiries from the trial site. Using their medical background they can have doctor-to-doctor discussions about the management of very sick and medically complex patients particularly in relation to serious adverse events. For example, when a serious adverse event is reported from the trial site to the company the Medical Adviser will review the information, will speak with the Investigator and/or study nurse to gain more information, and will liaise with Drug Safety Physicians in head office to assign causality (ie to determine whether the event was related or unrelated to the drug being administered). This requires the Medical Adviser to have a practical working knowledge of medicine, to understand how the patients are being treated, to understand the protocol and the drug’s mechanism of action and to provide medical advice to the Trial Investigator.
At the conclusion of a trial, once the data has been analysed and reported on, the Medical Adviser will either arrange a local Investigator’s meeting, or accompany them to a global meeting, where the results are discussed and patient treatment guidelines reviewed.
During the regulatory review process Medical Advisers will be working within teams to discuss questions from the regulators, through to the wording of PI and CMI documents. They will also accompany Regulatory Managers to Canberra for face-to-face discussions with the TGA, where their contribution will centre around the treatment of patients and the supporting data. Medical Advisers will also provide input into the reimbursement process by assisting Health Economists to develop strategies and submissions, based on clinical evidence, to support products being listed on the PBS. Once a product has been marketed Medical Advisers will assist their Medical Information colleagues in answering complex enquiries from healthcare professionals.
Within a pharmaceutical company Medical Advisers will also work closely with the Sales and Marketing department to support promoted products. This will involve advising on and approving educational materials to ensure compliance with the Medicines Australia Code of Conduct (eg claims being made; substantiating data; statistically vs clinically important result reporting); presentations and training sessions at product launches; working with healthcare advertising agencies on key messages and product positioning; through to representing the company on various subcommittees of Medicines Australia, and being the public face for any medically related issues (eg product recalls).
To be successful in their role Medical Advisers need a practical understanding of clinical medicine with hands-on pharmacological experience gained from currently or recently working in a major Australian teaching hospital (as senior resident or registrar).
Backgrounds from the following disciplines are therefore useful: Cardiology; Clinical Pharmacology; Emergency Medicine; Endocrinology; Gastroenterology; Haematology; Immunology; Infectious Diseases; Intensive Care; Nephrology; Neurology; Oncology; Respiratory; and Rheumatology.
Doctors entering the pharmaceutical industry generally have also undertaken research projects (eg PhD) or have been involved in company sponsored clinical trials (as co-investigator). They may also have completed an MBA or have other commercial experience.
In addition, to be successful within the commercial environment, doctors need advanced communication and presentation skills; the ability to work collaboratively within teams; the ability to influence colleagues in a credible manner and the ability to build engaging relationships with Key Opinion Leaders.
Career paths for doctors in Australia include taking on more senior roles (starting as Medical Adviser, Clinical Research Physician or Pharmaceutical Physician; and moving to Senior Medical Adviser, Associate Medical Director, Medical Director; Senior/Executive Medical Director). Depending on the company career progression involves responsibility for larger clinical research programmes in several therapeutic areas, the direct management of more staff, more administrative duties and more in-depth involvement with business initiatives. In addition there is more involvement with global medical strategic planning for new therapeutic compounds.
Career progression may also involve having responsibility for specialised areas (Pharmacovigilance, Health Outcomes/Market Access or managing Medical Science Liaisons) or transferring to a commercial department as a Business Unit Manager.
There are also opportunities to transfer regionally (eg as Regional Asia-Pacific Medical Director with responsibilities across multiple countries) or to head office (and oversee the management of global programmes in clinical research; regulatory and pharmacovigilance; or market access).
Sample interview questions for a Medical Adviser role:
What is your understanding of the role of a pharmaceutical Medical Adviser?
What interests you about this role?
What are your reasons for leaving clinical medicine and joining the pharmaceutical industry?
What do you see to be the benefits of working in the pharmaceutical industry?
What commercial experience do you have? ( eg jobs at school/university, being involved with a family company; working in a commercial role).
Tell me about your therapeutic area expertise?
How do you stay up-to-date with developments in your field?
Tell me about presentations you have given and conferences you have spoken at?
Give me examples from when you have trained people?
What is your understanding of the Australian Regulatory process?
What is your understanding of the Australian Pricing and Reimbursement process?
Outline your experience with clinical trials (eg as a co-investigator, attending investigator meetings, recruiting patients into clinical trials).
What is your understanding of the sales and marketing function of a pharmaceutical company?
Tell me about when you have worked in a team environment?
How would your colleagues describe you?
Describe to me how you develop relationships with people.
Describe how you influence people.