PhD Careers In Clinical, Medical, And Regulatory Affairs

I was defending my PhD in 6 months, and I still had no idea what I wanted to do.

What job did I want? Where did I see myself in 5 to 10 years?

My goal was to get out of academia and into industry – and as quickly as possible. Beyond that, I hadn’t thoroughly considered my options.

In fact, when I finally sat down to apply for jobs, I blindly searched for open positions using standard terms: “Researcher,” “Scientist,” “Biologist,” and so on.

As a science PhD, that’s what I was qualified for, right?

What I didn’t appreciate was how vast industry really is – and how many career options await PhDs like me.

There are five core industry career tracks that PhDs should consider, no matter their background: Information and Data Management (includes Patent Analysts, Medical Writers, Data Scientists); Research and Development; Business; Sales and Marketing; and last, but not least, Clinical, Medical, and Regulatory Affairs.

Clinical, Medical, and Regulatory Affairs is one career track that is often bypassed by PhDs.

Yet, many PhDs find fulfilling careers in these roles.

One Cheeky Scientist member recently shared how happy they were to transition into regulatory affairs:

“I had no idea what regulatory affairs was just a little over a year ago, and now moving into this field has been one of the best decisions.

The work/life balance is amazing and most professionals work either 100% remote or hybrid. And most importantly, I love making strategic regulatory decisions on how to put a product on the market.” 

Today, I will discuss the many exciting positions found within clinical, medical, and regulatory affairs that offer PhDs meaningful life-long careers.

Why Clinical, Medical, And Regulatory Affairs Are Booming

Clinical, medical, and regulatory affairs departments are growing at exponential rates.

Medical affairs has grown 300% over the past decade; the global clinical trial service market was projected to hit $64 billion by 2020; and the number of vacancies for regulatory affairs has increased by over 95% nationwide.   

Why is this?

Much of it is thanks to recent scientific advancements and changes in the FDA approval process – we now have more drugs entering the market than ever before.

This means that a greater number of novel drugs are produced, more clinical trials are conducted, and the need for regulatory oversight has increased.

6 In-demand Jobs In Clinical, Medical, And Regulatory Affairs

If you’re like many PhDs, you’re motivated by the prospect of making a positive impact on the world. If this is the case, then look no further than clinical, medical, or regulatory affairs.

In these roles, you’ll be testing the efficacy and safety of a drug or service and helping to ensure that federal regulations are met.

While most of these positions are in the private sector, there are also opportunities to work in the public sector or with a government organization.

Underneath the umbrella of clinical and medical affairs, there are also different positions to choose from – providing PhDs with plenty of options.

1. Clinical affairs positions 

Many PhDs think that only physicians and pharmacists are hired into clinical positions. While this may have been true in the past, now, companies are seeking out PhDs to fill these roles.

What companies are seeking are highly educated people who can communicate effectively with research staff and clinicians; analyze and interpret clinical study results; and stay current with the ever-changing regulatory landscape.

This makes PhDs highly coveted candidates.  

This is especially true in today’s clinical environment.

Clinical trials are becoming more complex. This means that clinical trials conducted today require more resources and more professional support.

And currently, the demand for clinical affairs professionals far exceeds the supply.

Underneath clinical affairs, PhDs can choose from a variety of roles. You could be a clinical trials project manager, a clinical research associate, or a clinical data manager.

While all these positions are working towards the operation and completion of clinical trials, each one has a very specific function.

Clinical trials project manager

As you can imagine, a clinical trials project manager manages all facets of the clinical trial process. They are the central hub that coordinates researchers, clinicians, and drives the overall clinical experience towards completion.

In this role, you’d be accountable for the successful delivery of each project; ensuring that deadlines and budgets are met, quality standards are maintained, and that trial operations comply with federal regulations.

However, if you aren’t keen on managing largescale projects, then perhaps a job as a clinical research associate would interest you.

Clinical research associate

Clinical research associate positions are great for those who want to remain close to the research. And while you wouldn’t be conducting the research yourself, you’d be fully emerged into the day-to-day of research operations.

Clinical research associates are responsible for organizing and overseeing the overall clinical study process: contacting potential participants, reviewing the medical history of each candidate, reviewing and interpreting study data, and writing reports.

On the other hand, if you’re more interested in collecting, analyzing, and interpreting study data, then a job as a clinical data manager may be a good fit for you. 

Clinical data manager

As a clinical data manager, you’d oversee all aspects of study-related data – designing the data framework; analyzing and interpreting data throughout the study; and maintaining data security, ensuring that study data is collected and stored in compliance with federal regulations.  

2. Medical affairs positions

The medical field is evolving.

From the way healthcare providers treat patients, to drug discovery methods, to the way clinical studies are conducted.

All these scientific advancements have resulted in a highly complex medical landscape – one which requires clinical and scientific professionals capable of transforming esoteric data into practical medical application.

This is where medical affairs come in.

Broadly speaking, medical affairs departments are the communication bridge between a company and the medical community.

They’re the subject matter experts.

And who, other than a PhD, is better suited to become a subject matter expert?

There are two major positions that PhDs are hired into: medical science liaison and medical affairs associate.

Medical science liaison

Medical science liaisons (MSLs) are the people in the field speaking directly with the consumer.

Their primary objective is to educate the consumer on a product’s proper use/application, and better understand how a product is operating in the real world.

To do this, they must establish and maintain strong professional relationships with the key opinion leaders (KOLs) in healthcare – physicians, pharmacists, and other professional medical staff.

MSLs communicate relevant clinical and scientific data to KOLs, listen to their needs, and determine how a product can meet the needs of the individual or organization.

To be clear, this is not a sales position. In fact, regulations strictly enforce the division between these two roles.

MSLs can speak to topics that are considered off-label and discuss treatments that are not yet approved. A salesperson cannot do this – they must adhere to FDA-approved on-label messaging.

MSL positions are some the most client-facing in industry and involve a good deal of travel; most MSLs travel up to 70% of the time.

If you’d prefer a more in-house position, medical affairs associate may be a better option.

Medical affairs associate

The responsibilities of a medical affairs associate include educating department members, ensuring the needs of the KOLs are being addressed, and providing informational services to healthcare providers.

They also work closely with regulatory affairs to ensure that all written documentation is accurate and adheres to the appropriate regulatory guidelines.

In essence, they are the go-between for the company – ensuring that the lines of communication remain open between the MSLs in the field and the in-house employees.

3. Regulatory affairs positions

For every dollar spent by the American consumer, 25 cents goes towards products or services regulated by the FDA.

That means that at least a quarter of US products have gone through some sort of regulatory approval process.

Regulatory departments are found in all sectors of industry – this includes medical technologies, medical equipment, implanted devices, biotech, and food science.

With a projected job growth of 8% per year until 2029, there’s no shortage of regulatory opportunities for PhDs.

And as the pace of innovation quickens, the need for highly competent regulatory specialists will only increase.  

Regulatory affairs specialist

Regulatory affairs specialists are responsible for knowing the regulations that apply to their area of industry. They educate employees on the legal standards that pertain to their work and ensure that the company complies with all necessary regulations.

Depending on the field, you may also be charged with regulating physicians’ prescribing practices, or the relationship between a physician and a company.

Regulatory affairs specialists also establish and update internal guidelines, oversee product development, and assess product quality.

PhDs are highly sought after for these positions. After all, you spent years diligently documenting experiments in a lab notebook, creating lesson plans and protocols, and following lab safety guidelines.

Concluding Remarks

Clinical, medical, and regulatory affairs offer PhDs a wide range of exciting positions. If you want a clinical job, you can work as a clinical trials project manager, a clinical research associate, or a clinical data manager. If you’d rather have a role that stays close to the science, then perhaps working as a medical science liaison or a medical affairs associate would be a great fit for you. If, however, you’re interested in developing or enforcing regulatory requirements, a job as a regulatory affairs specialist provides PhDs with exciting opportunities. All these positions are innovative, and require strong analytical, interpersonal, and communications skills. PhDs who excel in these types of roles are adept at building strong professional relationships and can work in an innovative space. Once you’ve identified the career track that best fits your professional lifestyle, you’ll be able to make more informed decisions throughout your job search.

If you’re ready to start your transition into industry, you can apply to book a free Transition Call with our founder Isaiah Hankel, PhD or one of our Transition Specialists. Apply to book a Transition Call here.