Case studies: Study director/drug safety team lead: Tina

Tina graduated with a PhD in Biomedical Science from Imperial College, having previously gained a degree in genetics from the University of York...

I developed advanced problem-solving skills during my PhD, and the ability to work independently as a scientist. I chose toxicology as a career because I wanted a change from basic research.

I spent 18 months in a small biotech company at Imperial College in London just after finishing my PhD, where I was responsible for all in vivo work within the company. After that I moved to Pfizer, where I worked in research primarily developing new animal models of respiratory disease for three and a half years before moving into toxicology.

I got my current position by responding informally to an internal advert. I emailed the department head to see if he thought my skills were suitable for the study director role. I then had formal interviews with the head of department and two other senior members of the team before being offered the role.

My subject of study wasn't particularly relevant to gaining my current job. However, I think having a PhD is always going to be a big advantage, as it shows that you have a certain level of experience and independence, even though your actual hands-on skills may not be directly relevant.

I think a big part of me getting my current role was down to previous experience at Pfizer, and also down to whether I had the right attitude for the role and the department. Most graduates in my department come with a tox background. However, there are a number of people without previous tox experience who have joined our department from elsewhere in the company.

So far in my current role, I have been responsible for study directing short non-regulated studies, and I am also in training for regulated studies. I spend a considerable amount of time advising discovery project teams on safety strategy, scheduling studies and chasing people to make sure timelines are met. I carry out literature reviews for the safety aspects for new targets in Discovery. There has also been a fair amount of process development as the general toxicology group is quite new at our site.

On a day-to-day basis, I keep up regular contact with various project teams (face-to-face meetings, e-mail, phone), ensuring that time lines for planned studies are being met, and advising on future studies. As a study director, I set up protocols and monitor my studies. In addition, I gather and summarise data from past studies and draft the reports. I also spend time interacting with various contributing scientists, to understand findings in my studies.

Since starting in this role, I have undertaken GLP training (through BARQA) and a number of in-house training sessions for the drug safety team lead role. I am starting an MSc in Applied Toxicology at University of Surrey in October, and will be doing that on a part-time basis while working.

I like the fact that my job is very varied and challenging. I am on a steep learning curve at the moment, as I am not a toxicologist by training and have only been in this role for eight months. However, I find that quite invigorating. There is also a very clear medium-term career path in terms of stepping up project and study responsibilities.

I enjoy the interactions with a wide variety of people, including Discovery project teams, pathologists and other contributing drug safety scientists. The only less favourable part of the role is that working for a large organisation means that there are a lot of complicated processes that have to be followed.

To be successful in this role, it is essential to have good people skills and organisational skills, and a sound scientific background. You also need to work collaboratively and proactively.

Getting a job in large pharma is generally quite difficult, and graduates will probably be recruited mainly based on relevant experience and qualifications. So for toxicology, as a graduate it will be very important to have the right qualifications. However, as large pharma are quite dynamic places that go through changes regularly, there is often a lot of opportunity to move around within the company, as was the case for me.