Careers Pathways in Drug Discovery: From Bench to Commercialization

Drug development is a very complex process that can take multiple years to compile enough supporting evidence to select a target in a drug discovery program.¹ Throughout the process, healthcare workers of different disciplines play essential roles. This article aims to highlight where healthcare workers can have a career across drug discovery and commercialization. Drug development begins with scientific discovery, where researchers identify disease pathways, biological targets, and potential therapeutic mechanisms. This work is largely driven by PhD scientists in biology, chemistry, and pharmacology who design assays, screen compounds, and validate targets. Pharmacists, MDs, and nurses, which I refer to as “healthcare workers” for the remainder of the article, highlight unmet medical needs, treatment gaps, disease progression, patient outcomes, and barriers patients face in managing disease. 

Researchers then screen thousands of compounds to find “hits” that show promise of interacting with the target. Hits are refined into more potent, selective, and stable “lead” compounds.¹ After a lead is identified for its potential clinical value, researchers evaluate its pharmacokinetic and pharmacodynamic, PK/PD, properties as well as potency, selectivity, membrane permeability, stability, and off-target activity. PhDs, usually in medicinal chemistry or computational biology, drive structure–activity relationships and modeling. Healthcare workers help assess how a potential drug compares to existing therapies as well as patient usability considerations that could shape formulation decisions. In addition, those with expertise in pharmacokinetics or pharmacometrics can support PK/PD modeling, dose predictions, and simulation efforts that predict how the drug might behave in humans. Knowledge of dosing, absorption, and therapeutic classes helps shape compound refinement.

When a lead enters preclinical development, it undergoes in vitro and animal studies to assess toxicity, organ effects, therapeutic index, toxicity, carcinogenicity, and reproductive risks.¹ Toxicologists, pharmacologists, and pathologists lead the design and interpretation of these studies. Healthcare workers working in safety sciences or regulatory help interpret toxicology results to determine clinical risk and provide clinical context to animal safety findings. Those with regulatory or toxicology training may work in drug safety groups that design or review preclinical testing plans to ensure that studies align with FDA and ICH guidelines. They also interpret early safety signals that may impact eventual human dosing strategies.

After the Investigational New Drug (IND) application is approved, Phase I clinical trials begin, usually in small groups of healthy volunteers. Phase I studies assess safety, tolerability, and preliminary PK/PD in humans.^2,3 MD investigators lead safety oversight, dose escalation decisions, and adverse event evaluation. Pharmacists help design clinical pharmacology studies and interpret PK/PD results. Nurses administer study drugs, perform monitoring procedures, and ensure protocol adherence at the clinic. Researchers and healthcare workers support data analysis and interpretation of results. The research team’s expertise ensures medication handling, blinding, and storage meet regulatory and Good Clinical Practice (GCP) standards.⁴

Phase II trials expand testing to patients with the target disease, refining dose ranges, and evaluating early efficacy.^2,3,5 Researchers and healthcare workers contribute as clinical scientists, medical monitors, or study coordinators who help optimize trial protocols, interpret PK/PD results, and identify safety trends. PhDs lead biomarker analysis and statistical modeling of outcomes. MD principal investigators oversee patient care and manage safety signals. PharmDs working as clinical scientists or study coordinators help design protocols, review medication interactions, and analyze PK/PD data. Nurses play a central role in screening patients, administering treatments, documenting outcomes, and providing hands-on patient care. The team works together to interpret clinical responses.

At Phase III, large global studies are conducted to confirm safety and efficacy.^2,3,6 These studies are complex, expensive, and closely monitored. PhD statisticians and epidemiologists manage complex trial logistics and analysis. Researchers and healthcare workers support protocol development, data analysis, safety surveillance, patient monitoring, and global regulatory strategy. Nurses ensure high-quality patient data through consistent patient monitoring, documentation, and adherence support. Together, the team’s understanding of real-world medication use helps shape patient selection criteria, endpoint definitions, and risk-mitigation strategies.

After successful Phase III results, the company prepares a New Drug Application, NDA, or Biologics License Application, BLA.^7,8 After rigorous review of the product’s safety, efficacy, benefit, and risk profile, the FDA may grant approval. If approved, the product moves into the commercialization phase. This includes manufacturing scale-up, supply chain planning, market access strategy, and post-marketing safety surveillance. Researchers and healthcare workers contribute to a wide range of capacities, including quality control, process engineering, analytical development, regulatory affairs, medical affairs, health economics, managed care strategy, patient education programs, adherence initiatives, and patient assistance programs. 

Once the drug is on the market, Phase IV studies and real-world evidence programs evaluate long-term safety, comparative effectiveness, and new indications.^2,9 Researchers and healthcare workers design real-world evidence studies and conduct comparative effectiveness research. Researchers and healthcare workers can be a part of pharmacovigilance teams monitoring adverse event reports, analyzing safety trends, and recommending label updates. 

The product then reaches patients in real-world healthcare settings. Among other responsibilities, healthcare workers educate and counsel patients on safe use and adherence, adjust treatment plans based on patient response, and manage follow-up care. Researchers and healthcare workers provide real-world clinical insights to manufacturers and safety teams to inform future drug design, labeling changes, safety improvements, and unmet need identification. Ultimately, this process ensures that drug development utilizes a scientific and real-world approach to discover and improve upon the standard of care. 

From your friends at RxTeach, we wish you and yours a very Happy Thanksgiving!

Resources:

1. Hughes JP, et al. Principles of early drug discovery. Br J Pharmacol. 2011;162(6):1239-1249. 2025.
2. National Institutes of Health. NIH. Turning Discovery into Health. NIH Clinical Research Trials. 2025.
3. University of Cincinnati College of Medicine. Clinical Trial Phases Defined. 2025.
4. Citi Programs. Good Clinical Practice (GCP). 2025.
5. Torres-Saavedra PA, Winter KA. An Overview of Phase 2 Clinical Trial Designs. Int J Radiat Oncol Biol Phys. 2022;112(1):22-29. 2025.
6. National Institutes of Health. NIH. Grants and Funding. Phase III Trials. 2025.
7. Food and Drug Administration. FDA. New Drug Application (NDA). 2025.
8. Food and Drug Administration. FDA. Biologics License Applications (BLA) Process (CBER). 2025.
9. Suvarna V. Phase IV of Drug Development. Perspect Clin Res. 2010;1(2):57-60. 2025.

*Information presented on RxTeach does not represent the opinion of any specific company, organization, or team other than the authors themselves. No patient-provider relationship is created.