I recently discovered a blog by a medicinal chemist who has shared some interesting career insights. Medicinal chemistry, or pharmaceutical chemistry, is the discipline of designing and synthesizing new drugs, and it can be a very interesting career pathway for chemists looking for a job in the pharma or biotech sector.
In his post “Life with a Drug Discovery CRO“, the author describes what it was like to work for a contract research organization that specialized in combinatorial chemistry, synthesis, scale up and process development on behalf of big pharma clients.
How it worked for us in med chem was we would be presented with a project (in varying detail and with varying amount of leeway in our allotted tasks) with some fixed length of contract. Most were annually renewable and many continued for multiple years. The customers in question were a mix of pharma and start-up: for the established players, we were outsourcing for a project they did not have the internal capacity for (usually because there were more pressing projects and/or synthetic challenges to overcome). For the start-ups, we were their chemistry department.
The Regulatory Science program at the University of Southern California offers a variety of graduate certificates, a Masters program, and a new Doctorate geared towards regulatory affairs professionals. In the Regulatory Science program, students learn how to guide medical products and foods through the complex regulatory and reimbursement paths required to bring them to market. Regulatory Affairs is an incredibly important part of the drug development process, and in a very real sense plays the key role in determining the success or failure of a drug development program. Ultimately, it’s a company’s regulatory affairs team that must make the case to the FDA that a drug is safe, effective, and deserves to be on the market.
Quintiles, the world’s largest contract research organization, produced this series of “South Park”-style videos promoting careers with the firm. CROs can be a great place to start a clinical research career because they provide exposure to a variety of clinical trial protocols and therapeutic areas. The Quintiles website includes a journal that gives an idea of how a clinical research associate spends her time on site visit and office days.
Here’s an amusing look at a day in the life of a CRA (Clinical Research Associate) on a site visit. This video is a parody, but it does give you a sense of what site visits are all about.
A CRA may spend 60-80% of their time on the road conducting these visits. Their job is to monitor the conduct of clinical trials, ensuring that research sites are enrolling patients and carrying out the trial correctly, following both the trial protocol and ICH-GCP conduct guidelines. They review a lot of documentation, check site supplies and generally watch out for problems.
When there are problems, a CRA needs to help get the clinical site staff back on the right track, and so they need to have excellent communication and negotiation skills. It can take a lot of diplomacy to get clinical investigators and their staff to change the way they do things in a busy clinic!
The sound in the embedded clip isn’t synchronized quite right. You can see a higher-quality version at the ResearchPoint site. They are the CRO (Contract Research Organization) that created the video.
You can read more about what a CRA job is all about in this earlier article.
When you’re looking to get your foot in the door and find your first job in the pharma industry, sometimes it’s difficult to know exactly what a particular job entails.
If you’ve ever wondered what a typical day is like for a clinical research associate, then you might be interested by the story of Ann, a lead CRA for the UK-based firm CDSS. When it’s time for a site visit, Ann begins her day at 5am and works through to 8 o’clock.