A Safety Physician Transitions to Clinical Development

A Physician’s Transition to a Non-Clinical Career in the Pharmaceutical Industry

“I had to adjust my mind frame; as physicians we are used to helping one person at a time – curing one person’s hot flashes, delivering a baby… in pharma, I’m not pleasing any one person, but globally helping lots of women”

~~ Karla Loken, DO is an OB/GYN and Fellow of ACOG

Karla is an obstetrician/gynecologist and has held two different roles (Drug Safety and Clinical Development) in the pharmaceutical industry.  (BONUS – Karla’s current experience is in a device company – read more about that later)

Karla’s professional story:

  • OB/GYN, FACOG
  • Private Practice x 8 years* in Colorado
  • Moved to Indianapolis to teach in academics/residency program x 3 years
  • Transitioned back to private practice x 3 years
  • Involved in a near fatal car accident that led to significant nerve damage and inability to continue operating as an OB/GYN
  • Eli Lilly – Safety MD x 2 years
  • Hologic – Head of Clinical Development, Gynecologic Surgery (as of June 2020)

*all time periods are approximate

During our conversation, Karla said this was her single best piece of advice:

“your brain is always valuable” 

Karla shared this advice when we were discussing the struggle she went through after a car accident took away her ability to operate.  She relayed a story of how difficult a reminder she had when she was at a medical conference where a company representative asked if she wanted to practice using the robotic device that she had actually been hired to teach to residents in Indianapolis.

Karla’s Transition to Pharmaceutical Industry:

Being in Indianapolis, Karla was surrounded by people that work at Eli Lilly. 

Lilly is a large pharmaceutical company with its headquarters in Indianapolis. 

            ~34,000 employees (~11,000 of which work in Indiana!)

            products marketed in 120 countries

            global company with facilities in 8 different countries 

Find more information about careers at Lilly

Her suburb of Indianapolis is a popular place for Lilly professionals and Karla met a psychiatrist that worked at Lilly during a holiday party; this psychiatrist asked her to consider Lilly as a career transition.  She actually had conversations with him at three holiday parties before she decided to pursue this career path. This physician also introduced her to other physicians from Lilly to give her an opportunity to learn more.

As you read and learn more from The IndustryMDCoach, you will hear this lesson MANY times:

NETWORK!

You must be open to networking!

Actively explore your current network and always strive to build your network! 

Karla’s social network introduced her to the possibility of a job at Lilly AND also provided her the opportunity to discuss this career path with several other physicians from Lilly.

A day in the life as a Safety Physician at Eli Lilly:

What does a safety physician do?

A safety physician focuses on evaluating adverse/side effects reports and determining if they are related or not related to a specific drug.  This might be in the context of clinical trial safety data or from reports that the company receives from physicians, pharmacists, patients, etc. that are prescribing or using a marketed drug.  In this role, Karla had to learn all of the drugs marketed by Lilly, her role was not specific to a certain therapeutic area or drug.

Karla explained that she had to go through special credentialing and training when she first started to understand the regulatory rules involved in making the determination about relatedness.

Here is Karla’s description of the day-to-day work?

  • the same every day
  • lots of work on the computer
  • not much interaction with others
  • ~ 2 meetings/day
  • worked 3 days in office, 2 days from home
  • very little travel

Karla explained that she had started talking with another MD friend and colleague at Lilly that was also an OB/GYN and worked in Medical Affairs.  As she described, her safety job could be “tedious”; thus, she was starting to network within Lilly to determine if a different role would be a better fit for her personality and leadership skills. 

Karla mentioned several important positives about her experience at Lilly:

She had a great mentor at Lilly

Lilly is very family oriented and provided great benefits

She enjoyed participating in a women’s physician organization at Lilly where women MDs had the opportunity to mentor one another, share their journeys and be inspired to know “I could also do that!”

The job provided opportunities to not miss her sons’ soccer games, to sleep in the bed with her husband 7 nights in a row (which had not happened for 20 years!), and to practice self-care

Karla’s transition to Hologic and Clinical Development:

** Remember the bonus mentioned above? Hologic is a DEVICE company **

What is a DEVICE company??

Medical device companies develop medical devices and surgical instruments that diagnose, treat, or prevent various medical conditions. Examples of medical devices include pacemakers, artificial joints, ventilators, stents, etc.

(Physician roles in device companies are similar from a title and functional standpoint to those in the pharmaceutical industry)

So how did Karla land the role of Head of Clinical Development in Gyn Surg at Hologic?

She explains that she received a call from a recruiter that had seen her profile on LinkedIn and “she checked a lot of boxes” for the role.  The job was in Boston and her family wasn’t in an ideal position to relocate given her twin sons being in high school.  However, with the encouragement of her husband (also a physician, who followed Karla’s path to an MD role at Lilly!), she decided to pursue the role.  Because of Covid-19, the job was available for someone that would work remotely (although she does travel to Boston frequently now). 

Now Karla’s days are highly varied and she describes her work as

  • “fast-paced” and “crazy fun”
  •  working with engineers and research lab personnel to develop products
  •  speaking with physicians to answer questions they have about using a device “off-label”

(off-label means that a drug or device is not approved for that specific reason; however, physicians can use drugs or devices off-label… certain people at a drug or device company, like a physician can answer questions and have peer-to-peer conversations, within limits)

  • due diligence (evaluating companies or products that Hologic might want to acquire)
  • writing a regulatory submission
  • traveling to a clinical trial site
  • AND… “my evenings are my own”

Here’s a great example of the fast-paced environment Karla is working in…

After only 2 days at Hologic, Karla had to rapidly learn a device technology because she was needed at a clinical site to demonstrate it for another physician! Karla relayed this story with little trepidation as she is confident in her skills and also had the support of a company engineer that was involved in the device development. It’s a telling example of needing to “jump right in” and also to trust in your own ability!

At my first job in industry, I was told that I could “sink or swim” – Karla definitely decided to swim! And I would remind physicians reading this that we are all very capable of swimming!  

OK! so now you have a really good sense of two roles for MDs in pharma – Safety Physician and Clinical Development (at a Device company).

So many great topics arose during my conversation with Karla!

I’m going to finish with …

PERSEVERANCE

Karla did not get the first job she interviewed for at Lilly.

Lilly was looking for someone with internal medicine and diabetes experience…

In the interview, Karla translated her maternal diabetes experience from OB/GYN but that did not fit the company’s hiring needs for that role

It’s important to realize that as physicians we cannot internalize a “no”

we have to keep trying, keep searching for the right fit –

the right fit for YOU and a company!

Karla’s words of advice regarding perseverance include:

“The right fit might not be easy to find, DON’T GIVE UP, there are so many roles for MDs in industry”

“it’s not a one size fits all” … the roles are broader than all the medical specialties”

“give it a try – what do you have to lose?”

** Karla and I had such a great discussion I can’t cover it all in one post!

In another post I’ll focus on our detailed discussion about the adjustment to the pharma industry for MDs **