Functional Areas

Early-Phase Clinical Development encompasses research from preclinical studies through phase 1 and 2 trials of the drug development process. These trials are the first time an exploratory compound is studied in a human population and are commonly known as “first in human” trials. As a clinical research scientist, pharmacists assume lead roles in:

  • Designing and managing clinical trials
  • Study protocol development
  • Selecting primary investigator and trial sites
  • Ensuring proper data collection and interpretation
  • Determining the best dose of the medication for later studies
  • Reporting adverse events
  • Publishing clinical study reports and manuscripts

Late-Phase Clinical Development encompasses research from phase 2 and 3 human trials of the drug development process.

In addition to the activities in Early-Phase Clinical Development, pharmacists in Late-Phase Development also have the opportunity to participate in:

  • Planning investigator meetings
  • Chairing international clinical trial team meetings
  • Overseeing deliverables from various external contractors
  • Study protocol development

The marketing department is responsible for strategic implementation of the advertising and promotion supporting a company’s products. A pharmacist in Market Research/Business Analytics generally helps to:

  • Analyze past and present market data to monitor current and future trends
  • Forecast market trends
  • Create patient population evaluation models
  • Identify unmet medical and pharmaceutical care needs

In this role, pharmacists:

  • Critically analyze and evaluate evidence-based medicine
  • Plan and implement continuing education programs and materials
  • Collaborate and network with key opinion leaders from industry, managed care, and academia to create promotional and educational programs
  • Act as a key member in the development of publication plans

A pharmacist in Regulatory Affairs may:

  • Develop and provide clinical development and Regulatory strategy
  • Create and compile submissions to Health Authorities including Investigational New Drug Applications and New Drug Applications
  • Interact with FDA and Global Health Authorities such as the EMA
  • Review and approve advertising and promotional material

MSLs are therapeutic specialists who coordinate the communication of clinical information between pharmaceutical companies and medical experts.

The MSL is a field-based associate who collaborates with and communicates information to:

  • The sales force
  • Practitioners in the field
  • Clinical trial investigators
  • Internal stakeholders

A pharmacist in Medical and Scientific Affairs:

  • Provides expertise on global life cycle management
  • Collaborates with Global Brand Medical Directors and their teams
  • Integrates data from internal and external sources into actionable information for clients
  • Reviews and approves promotion and advertising from a medical perspective in compliance with FDA regulations

Pharmacists have found a niche in this department by:

  • Evaluating a product’s safety profile throughout its development and into its postmarketing stage
  • Participating in clinical development team discussions relating to adverse events
  • Integrating information from preclinical safety trials to ongoing trials
  • Contributing to ongoing safety documents submitted to health authorities

The Health Economics and Outcomes Research (HEOR) group helps to identify, measure, and compare the costs and consequences of health-related courses of action to assign a “perceived” value to a pharmaceutical intervention.

A pharmacist in HEOR can:

  • Compare the economic effect of 2 or more drug products
  • Assist in the development of drug formularies
  • Develop national or international clinical practice guidelines