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Prescription for innovation: The evolving role of industry pharmacists

Prescription for innovation: The evolving role of industry pharmacists

By Ngoc Phuong Mai Le, PharmD, BS

There are many exciting career pathways a pharmacist can pursue, including the pharmaceutical and biotechnology industry sector. Industry pharmacists play a vital role in the drug development process. From accelerating new drug approvals to managing a product’s lifecycle, they work to ensure that safe and effective treatment therapies across multiple therapeutic areas become available to patients.

In this article, I will discuss common functional areas that industry pharmacists typically work in, the use of artificial intelligence (AI) to accelerate drug development within the pharmaceutical industry, how to position yourself for an industry role, and resources for success.

Common functional areas

The pharmaceutical industry can be complex to navigate for those who are unfamiliar with the general landscape. Some common functional areas within the pharmaceutical industry for pharmacists include:

Medical Affairs
Medical Affairs professionals communicate scientific and clinical information to the community, serving as bridge between the company, health care providers, and patients.1 Medical Affairs’ work may include responding to drug information questions, preparing presentation slides for conferences and meetings, disseminating scientific information, and gathering insights from key opinion leaders in the field.

Clinical Development
Clinical Development professionals design and manage clinical trials from phase 1 to 3, conducting data analysis and translating complex findings into application for drug development.2 They also build clinical study protocols and prepare Investigational New Drug filing for submission to regulatory agencies, such as FDA or the European Medicines Agency (EMA).

Regulatory Affairs
Regulatory Affairs professionals support the process of registering new health care products to gain approvals by the FDA or the EMA.3 They collaborate closely with other functional areas to provide strategic planning for the product’s life cycle, ensuring compliance with regulatory agencies to maintain the products’ presence on the market.

Pharmacovigilance
Pharmacovigilance professionals detect safety signals to assess and report any adverse effects related to drug products for awareness and prevention purposes.4 Although clinical trials provide crucial information on drug safety and efficacy, many adverse effects only emerge during postmarketing surveillance, requiring careful monitoring conducted through pharmacovigilance activities.

AI implementation within the pharmaceutical industry

With the rapid development of technology, AI emerges as an innovative and important tool to accelerate the drug discovery and development process within the pharmaceutical industry. Many pharmaceutical companies have expressed interest in exploring and implementing AI due to its effectiveness in reducing the drug discovery duration from 6 years to 1 year, potentially saving about $26 billion for research and development cost.5 By shortening the time for drug development with AI, new therapies can be discovered more quickly and manufactured more efficiently, enabling access to innovative medications for patients with different comorbidities and disease states.

The drug development process encompasses multiple stages, including the discovery of new molecules in the lab, compound testing during preclinical studies, and investigation of new drugs in clinical trials. AI can be used during these stages to identify lead compounds, predict structure-activity relationship and pharmacokinetic properties of new drugs, and streamline clinical trial enrollment through selection criteria and biomarker screening.6 Companies and organizations also utilize AI to manage patient data and medical records, provide clinical support for patients and health care providers, and improve precision medicine by incorporating genetic information to highlight mutations associated with certain diseases and cancer risks.7

Apart from the drug discovery and development process, AI is also useful in supporting pharmaceutical industry professionals with their internal workflow, project management, and scientific communication. For example, AI can build general frameworks for crafting technical and clinical reports, extracting medical information from different sources and simplifying languages in lay terms to develop concise resources for collaborators from different backgrounds.8 Gathering scientific information, generating educational materials related to new drugs and collecting medical insights from key opinion leaders can be a time-consuming process. By leveraging the use of AI for preliminary tasks, industry leaders can focus their expertise on higher-level synthesis and decision-making processes.

Transitioning to a pharmaceutical industry career

Seasoned pharmacists and new practitioners looking for a career transition to the pharmaceutical industry should focus on developing transferrable skills, such as scientific communication, leadership, teamwork, time management, strategic thinking, problem-solving, and cross-functional collaboration. Practicing pharmacists can leverage their patient care experiences and knowledge of the health care system to strategically align their skills and expertise with the requirements of industry roles.

In addition to tailoring your resume or CV to match the job descriptions, make sure to:

  • Stay up to date with the news, especially the innovative technologies used in drug development, such as AI, targeted gene therapies, digital health tools, and advanced drug delivery systems. Take a certificate course, attend a conference, or connect with field experts.
  • Consider a postgraduate training program, such as a biopharmaceutical industry fellowship. As a current industry fellow, I’ve gained hands-on experiences in clinical research, drug development and medical affairs. I’ve had the opportunity to conduct research for an NIH-sponsored clinical study, deliver scientific presentations at meetings, and travel to conferences to network with industry peers. These experiences provide valuable knowledge and transferable skills essential for the pharmaceutical industry.
  • Research the companies, therapeutic areas, and clinical pipelines that you’re interested in working with. Connect with a career coach or have industry professionals review your CV. Remember: Networking is an important part of the process.
  • Use resources from pharmaceutical industry organizations, including the Industry Pharmacists Organization, Medical Affairs Society, Regulatory Affairs Professionals Society, Association of Clinical Research Professionals, and International Society of Pharmacovigilance.

Ngoc Phuong Mai Le, PharmD, is a medical affairs fellow at the University of North Carolina at Chapel Hill, Eshelman School of Pharmacy, sponsored by United Therapeutics Corporation. She serves as the 2025–2026 chair of the APhA New Practitioner Community Member Engagement Workgroup, and Industry/Medical Affairs Community member-at-large. Her expertise includes precision medicine, clinical research, medical affairs, and pharmaceutical sciences. Outside of pharmacy, Mai enjoys summer activities, traveling, and exploring new places.

References

1. https://medicalaffairsspecialist.org/blog/what-is-medical-affairs
2. https://crisprmedicinenews.com/news/explainer-the-clinical-development-path/
3. www.raps.org/who-we-are/about-the-regulatory-profession
4. www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance
5. www.scilife.io/blog/ai-pharma-innovation-challenges
6. www.uspharmacist.com/article/artificial-intelligence-and-the-future-of-specialty-pharmacy
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC9836757/
8. www.mckinsey.com/industries/life-sciences/our-insights/generative-ai-in-the-pharmaceutical-industry-moving-from-hype-to-reality

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Posted: May 8, 2025,
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