It IS possible to transition between Medical Affairs and Clinical Development!
Jennifer Sloane-Lazar is a rheumatologist and Clinical Research Director at Sanofi. She completed her medical training in New York, moved to Philadelphia where she worked at both Temple University Health System and Thomas Jefferson University Hospitals as a clinician and fellowship director for seven years.
Her clinical practice and fellowship director responsibilities in the academic center were rewarding but, after many years of clinical practice, Jennifer decided
she wanted a different way to help people
Therefore, she sought to find a different way to contribute.
When she started evaluating other career options, she admits that she did not fully understand any of the roles in the pharmaceutical industry. GlaxoSmithKline (GSK) was not far from her home and she decided to “apply to all the jobs they had”.
She was given an offer as a Medical Affairs Director in the Immuno-inflammation unit supporting the drug, sirukumab. Sirukumab was an IL-6 receptor antagonist that was ultimately not approved. However, during her time at GSK she worked on the launch planning for sirukumab and learned much about what is involved in preparing to launch a drug.
(“Launching” a drug means preparing for its commercial availability after a drug is approved by a regulatory authority.)
Rheumatology is a key therapeutic area for GSK and thus, Jennifer believes her rheumatology experience was a “huge attraction for them”.
Jennifer discussed her experience in Medical Affairs at GSK:
at GSK, Medical Affairs does not participate in any clinical research, even phase 4 studies
(Phase 4 studies are studies conducted with drugs that are approved or “marketed”)
Jennifer and I discussed the differences in Medical Affairs at different companies – at some companies Medical Affairs is responsible for phase 4 trials, at other companies they are not.
If you are evaluating Medical Affairs roles,
it is important to understand the division of roles and responsibilities
at different companies…
Medical Affairs is not an easy career path to describe…
Jennifer has a great description of Medical Affairs:
“providing medical/clinical support for drugs after they come to market”
Her responsibilities included “making sure that information was medically correct, speaking to practitioners about any medical concerns about a drug”. She also had the opportunity to work on mepolizumab which was the first product that was approved for a rare disease, EGPA (formerly known as Churg-Strauss Syndrome).
After approximately 4 years at GSK, Jennifer felt something was missing; that something was more clinical development experience.
This is where NETWORK (a theme of many of my blog posts and the experiences of multiple physicians in the pharma/biotech industry!) played a role.
A colleague introduced her to the hiring manager at Sanofi and that colleague’s personal recommendation was the impetus for Jennifer’s being hired in Clinical Development. Interestingly, I found it great that Jen said her transition to Clinical Development was not that difficult. She attributes that to having a supportive manager and also being able to use her clinical skills and training. She continues to work in the area of rheumatology, supporting an IL-6 receptor antagonist, sarilumab, for giant cell arteritis and other rheumatoid diseases. She also had a great opportunity to be involved with the study of this compound in patients with Covid-19.
In Clinical Development her responsibilities include:
contributing to clinical trial protocols,
Investigator Brochures (IBs),
Clinical Study Reports (CSRs),
and being a Medical Monitor where she is responsible for data review.
When asked about the most challenging part of transition to the pharma industry, Jennifer reflected on “understanding hierarchy”.
“In medicine you are a solo operator; in a pharmaceutical company, you have to understand the hierarchy, even when you don’t agree with a decision being made you cannot always speak out… it was difficult to figure out when to speak up and when not to say anything”.
She also greatly appreciates the importance of a great manager. Related to this, her final words of wisdom involved interviewing.