Physician Roles in Pharma
Do you ever wonder what types of jobs or careers are available for physicians who want to transition to pharma? If so, this article is for you.
Physicians will typically work as medical directors in one of the following areas: Clinical research/clinical development, medical affairs, pharmacovigilance, and some may even pursue a medical science liaison (MSL) position. Before we take a dive into what each position entails, lets get some jargon out of the way.
When a clinical trial is done in human subjects there are three main groups involved in the conduct of a clinical trial. These include the Sponsor, the clinical investigators (PIs) and the institutional review board (IRB). The Sponsor is the company that takes responsibility for and initiates a clinical investigation. For example, this might be a large pharmaceutical company like Merck, a small Biotech or startup, and even an investigator when it consists of investigator-initiated trials. The Sponsor may delegate clinical trial duties to a Contract Research Organization or CRO. The work of a physician in a CRO as a medical director is slightly different than the work of a medical director at a Sponsor company, but we will discuss that a bit later. The CRO may perform one or more of the Sponsor’s trial related duties, for example, medical monitoring, protocol development or regulatory submissions. The clinical investigators or PIs are the physicians in the clinics or hospitals that enroll and see the patients. The IRB is the body responsible for ensuring the studies protect the rights and welfare of human subjects.
Below we will discuss in more detail what each of these positions consist of.
Clinical Development: In clinical development, physicians often work at the forefront of drug discovery and in a multidisciplinary environment. The ideal candidate is one with clinical as well as research experience, however, that is not a deal breaker and physicians have transitioned into these roles without prior research experience. The medical director is often responsible for leading the clinical trial by means of protocol development/design, amendments, data interpretation, monitoring of the trial and reporting of the results as well as interacting with regulatory agencies such as the FDA. They help with preparation of documents for submission such as investigational new drug (INDs), new drug applications (NDAs), safety and annual reports. Medical directors may be involved in early development trials such as phase I or late trials such as Phase III. The physician will contribute to and often lead a cross-functional team with a diverse range of professionals and interact with sites as part of the trial monitoring process (or interact with a medical director from a CRO if they have delegated the monitoring duties). When the physician (at a Sponsor or CRO) act a medical monitor, they are ensuring the trial is run appropriately. They are typically the first point of contact by the PIs should any questions or concerns arise related to the study. The medical directors often collaborate with other groups, but also with key opinion leaders and attend scientific assemblies to stay up to date on the latest in the field. (Medical directors in CROs have similar functions, although there is not much regulatory involvement as that is often led by the Sponsor. CRO medical monitors can help with protocol development, safety reporting and trial monitoring as well). Click here to learn more about physicians in clinical development.
Medical Affairs: The main goal of the medical affairs department is to communicate accurate and clear scientific information within and outside the company. These physicians are the communicators. Physicians in this role will need to have an understanding of not only the patient’s but also physician’s point of view of a particular disease area and specific drug. The medical directors are often in touch with key opinion leaders, professional societies and other team members internally. They interpret data and understand the drug profile while supporting the real-world evidence initiatives regarding data generation. They support the media and educational ensemble for the assigned portfolio and disseminate current medical knowledge of their assigned product(s). A medical affairs physician will have a deep understanding of not only the science behind the product, but also the results of the studies and how to disseminate that information to others. They help with abstract and manuscript writing and publishing and present study results at conferences. They may also be involved in developing late phase clinical protocols (Phase IV) to help answer real world questions. In short, physicians in medical affairs not only communicate information, but build relationships with healthcare providers.
Pharmacovigilance: Pharmacovigilance physicians play an important role in ensuring safe and appropriate use of drugs and patient safety. In this role, physicians often collaborate with others in the team to identify, assess, monitor, and report the adverse events (AEs) observed in a study. The identification of AEs may lead to drug discontinuation or dose adjustment in a study. In addition, they generate safety reports and interpret adverse event data after communicating with PIs. They performed aggregate reporting and look for patterns or safety signals in studies. Click here and here to find out more about physicians in pharmacovigilance.
MSL: the position of medical science liaison or MSL is a position within the medical affairs department, however it is a field position. These physicians are often educators of their assigned therapeutic area. They form relationships with key opinion leaders and other community stakeholders as well as meet with healthcare providers to ensure understanding of the products they represent. They advocate and often educate on their respective products. The physicians often travel in their assigned region and their rich background allows them to often present complex scientific information in a form that healthcare providers will understand. They can be MDs/Dos, PhDs or PharmDs. For more information, check out ACMA’s – what is an MSL.
Other positions in pharma for physicians include regulatory affairs. In this role physicians coordinate the writing and submission of regulatory documents to agencies such as the FDA. Physicians may also work in Data Management or executive roles such a chief medical officer and executive medical director.
Whatever your skills and clinical experience, there is a spot for you in the pharmaceutical industry. Reach out to us at Nemury Group if you’d like to learn more about the transition process.