Interview: Anne O’Neill-Mathias, Head of Ethics and Compliance, Roche Pharmaceuticals
Published: Nov 21, 2017 By Seema Sharma
In our final article in the series exploring roles in the Pharmaceutical Industry, we speak to Anne O’Neill-Mathias about her work in ethics and compliance. She provides practical career insights about her successful roles in Industry to date, including her transition from academia.
Successful drug development in the Pharmaceutical (Pharma) Industry can take over a decade from its beginnings in the laboratory, to the treatment of patients in the clinic. Throughout this time, all processes must be conducted to strict standards, subject to compliance with existing regulation. There are also internal corporate standards to maintain, ensuring consistency within an organisation.
The role of regulatory affairs and compliance departments is implicit in ensuring that all current legislation and protocols that govern the development and use of medicines for patients, are adhered to.These include strict criteria for the licensing of drugs, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and marketing authorisation, amongst others.
"The role of regulatory affairs and compliance departments is implicit in ensuring that all current legislation and protocols that govern the development and use of medicines for patients, are adhered to."
Regulations vary on a country by country basis, so these departments need to be up to speed with all relevant legislation for the regulatory body, wherever their company operates globally. For example, in the UK the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for overseeing the quality, safety and effectiveness of medicines.
In this article, we interview Anne O’Neill-Mathias, who provides an understanding of what’s involved in a role in ethics and compliance in Industry. She discusses her unique career path, transitioning from academia and industry, with intuitive career tips she’s gained along the way.
What is your full title and what does you current role involve?
I currently work as the Head of Ethics and Compliance at Roche Pharmaceuticals, specifically for the functions of Biorepository and Sample Management. The samples we’re responsible for originate from clinical trials, and are often used for future exploratory research. I manage a group of 5 people, including 4 Compliance Managers and an Ethics Lead. We provide support to ensure samples are ethically used, with consent, in a way compliant with current regulation. We have to ensure we meet Good Clinical Practice (GCP) standards and everything is inspection ready for regulatory bodies like the Medical Health and Regulatory Agency (MHRA), or the Food and Drug Administration (FDA) in the US. Our Ethics Lead routinely has to answer questions from relevant ethical committees, for example, institutional review boards (IRB’s) in the US.
Can you briefly describe your career path to date, after completing your studies?
I completed a MSc. at Trinity College Dublin in Molecular Biology and Genetics. I was working on a project centred on graft versus host disease (GvHD) in bone marrow transplantation. During my studies, I also got the chance to do a secondment in France at a biotechnology company called Genset, based in Paris. I acquired many skills there, including genetic diagnostics techniques and cutting edge forensic work. The latter was one year ahead of the discovery of DNA fingerprinting.
After completing my Masters, an opportunity arose as my former manager in France was setting up a Biobank, in collaboration with the Royal College of Surgeons, Ireland. He contacted me to ask whether I would take a position there as Laboratory Manager and I accepted. My role there spanned close to 7 years before I moved to London, for a position with GlaxoSmithkline (GSK) as a manager in the pharmacogenetics department — a role in Research and Development. After a few years I progressed to a role as Head of Sample Management. This involved overseeing a large team, with members being split between the US and UK. After a total of 6 years, the company went through a few re-organisations and finally the site where I was working was ear-marked for shut down, so I chose to take voluntary redundancy. I had childcare responsibilities at the same, so it fitted in well and was a great time to take a 2 years break to spend time with my sons.
My next role was at Roche Pharmaceuticals, where many of my former friends and colleagues had gone to work after the GSK site was closed. They were advertising for a Compliance Lead role in Phamacovigilance, and they wanted a candidate with staff training, Quality Control (QC), biobanking and sample management experience. My previous roles and research experience held me in good stead for a successful application.
After I started, the department was audited within the first few months, so it was a busy and challenging time. I was working as part of a cross-functional team that sat within the clinical operations department. We supported several teams globally, including the biobanking and clinical trial study teams. The role required a lot of cross-cultural awareness and many meetings were conducted by teleconferencing. There were many stakeholders involved in decision-making, so a huge part of making the role a success was great communication.
"After I started, the department was audited within the first few months, so it was a busy and challenging time."
I had sat on the leadership team for a while as part of my Compliance Lead position. When a company re-organisation took place, I was made Head of Ethics and Compliance. I particularly enjoy coaching staff and also, the line management aspect of the role at the moment.
What are the highlights of your working career to date?
When I started my role at the Royal College of Surgeons in Dublin, I was given free reign to set up the laboratory. It involved building up a great team, setting up new processes, producing concepts of how things were going to run — then translating these into practice. It was a fantastic learning opportunity.
At GSK, I was involved in a very large infrastructure project for DNA storage. I had to produce the plan of how we would do this and then convert it into a reality. I enjoyed taking this project from an initial idea to delivering the final product.
Very shortly after having started my Compliance Lead role at Roche, I was informed we were undergoing a full corporate compliance audit within a few months. Consequently, there was a massive learning curve where I had to get to grips with my new role — and ensure everything was prepared within the timeframe. I genuinely liked the challenge involved. Seeing everything with a fresh new set of eyes after I joined Roche, and providing input and ideas during that initial period was also a highlight. Additionally, I have had a fantastic team and colleagues working with me at Roche.
What were the key influencers for you choosing this career path in Industry versus an academic career, after your PhD?
I had worked in collaboration with Pharma in my job as Laboratory Manager at the Royal College of Surgeons. The experience had peaked my interest in the sector. I was moving to London for personal reasons, so I thought it was an apt time to apply for a Pharma role. I was aware that it may involve less freedom in my work day-to-day, but liked the structured and organised approach in Industry. In academia, you can end up moving from grant to grant, whereas there is more stability in industry roles, people tend to stay at the company for a long time. The salary and benefits offered are often better.
However, there are a couple of things to bear in mind in Industry. Firstly, there is a consensus culture, so decisions can take a long time. Also, global working adds a great dimension to your role, but can also mean that things are not as nimble as they could be. There are a lot of meetings, and these can reduce productivity at times.
What do you enjoy most about your current role?
People are very forward-thinking and there are options to work from home, offering a healthy approach to maintaining a work/life balance. You have opportunities to travel, for example I go to San Francisco office regularly. I like the fact that you see the drug discovery process and how it directly relates to an end product that helps patients. You get to hear patient stories, which can be very fulfilling.
"People are very forward-thinking and there are options to work from home, offering a healthy approach to maintaining a work/life balance."
From your experience, what 4 key pieces of advice would you give researchers wanting to have a successful career path in Industry?
- Don’t have a rigid plan. It’s really best to take opportunities that come your way, rather than restricting yourself to a solid plan.
- Find a good mentor. Having someone that can help you identify your strengths and weaknesses can prove an invaluable help in your career.
- Do what you enjoy most. Choose a role where you enjoy your day to day job. Something that makes you want to go into work everyday.
- Finally, don’t underestimate yourself!
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- Royal College of Surgeons - https://www.rcseng.ac.uk/about-the-rcs/
- Medicines and Healthcare products Regulatory Agency - https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about
- Roche Pharmaceuticals - https://www.roche.com
- Anne O’Neill-Mathias LinkedIn - https://www.linkedin.com/in/anne-o-neill-mathias-3342ab35/
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