Madrigal Pharmaceuticals

Laura McAvoy

Patient Safety Steward

From Individual Contributor to Strategic Leader

In life sciences, some of the most effective leaders arrive at leadership sideways. I never set on my career path with the intent of being a leader, because I enjoyed the individual contributions I was making and felt like I was well-suited for the role. However, it’s my progression of unique experiences in industry, from regulatory operations, project management, medical writing, and safety science, that have equipped me with the knowledge and skills needed to make strong leadership decisions, while keeping sight of day-to-day operations.

I’m fortunate to be in a position where I still do “ground level” work but am also counted on to develop process, ensure compliance, and grow a high-performing team. This requires strategic decision-making, stakeholder management, and a keen understanding of my subject matter. Emotional intelligence is also extremely important. I understand that, as a fairly new employee, for example, I may need to demonstrate my expertise, work ethic, and reliability to develop the strong relationships in a matrix environment that are essential for my own success. I lead with empathy as much as I can, but it can often be a balance between meeting the needs of others while protecting boundaries for myself and my team.

Balancing Compliance, Efficiency, and the Patient Voice

In my role, regulatory requirements are paramount because the goal of my deliverables – aggregate safety reports - is to retrospectively “tell the story” of safety decisions, which are often complex, and almost always time-sensitive. Knowing the outcomes of these decisions directly impact patient safety, these reports are an opportunity to gain regulatory alignment on how my company intends to reduce risk to our patients and demonstrate a robust process that informs these decisions. Operational efficiency is essential, especially in smaller organizations, and at times requires that certain activities be deprioritized. It requires an understanding of both the regulatory requirements and safety decision-making, as well as skills in communication and strategic planning.

  Strong communication and clearly defined processes lead to improved cross-functional relationships and overall better outcomes.  

That clarity of process also shapes how I approach the cross-functional relationships that make or break complex reporting initiatives. Often my work is about getting busy individuals to prioritize providing the information my team needs, which can be challenging when they have their own functional responsibilities. I firmly believe that strong communication and clearly defined processes lead to improved cross-functional relationships and overall better outcomes.

Those cross-functional dynamics are also being reshaped by forces that go well beyond internal operations. Obviously, AI is a huge part of the current conversation, with demonstrated abilities to perform certain functions within this environment. However, it’s going to require a lot of thoughtful discussion to implement as a standard – from defining procedures, to ensuring appropriate “human in the loop” quality checks and decision points, to redefining roles and responsibilities.

Perhaps a more particularly relevant key trend relates to the importance of patient perspective, which can directly influence key risk management decisions. A patient’s unique situation can be eye-opening in this regard: A cancer patient with limited treatment options may be willing to take a medication with slight risk of severe immune reactions, while a patient with high blood pressure may not want to take a medication that is known to cause diarrhea, which, while a much less serious side effect, could prevent the patient from being comfortable in social situations and severely impact their quality of life. 

The Tools That Shape a Career in Safety

For professionals building careers in drug safety and regulatory affairs, the advice is straightforward, learn as much as you can: Ask questions, say yes to opportunities outside of your job description. Build your network: Find a mentor, learn how other functions of your company operate. Identify gaps and offer solutions. These experiences to draw from are like tools in a toolbelt, which can be quite powerful in progressing your own career path, whether it’s becoming a leader, developing specific subject matter expertise, or finding whatever success looks like to you. For me, it’s been about being in the fortunate position where my skills are utilized to directly provide value, But it’s taken that growing tool belt to get here, aided by a growth mindset, and confidence in my own abilities.