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Executive Search

Department Head Job Descriptions

Executive Search is about finding leaders who will avoid you avoid troublesome pitfalls, especially when it comes to FDA and other regulatory bodies. MEIRxRS places a number of executive level positions in FDA-regulated industries. VPs help a company to achieve its business goals in the most efficient manner possible. Some contribute by executing on a tight timeline, others by launching products and delivering sales revenues, and others by cutting costs and improving quality. MEIRxRS Executive Search specializes in the placement of Head of Drug Safety, Chief Science Officers, Chief Medical Officers, and Vice Presidents for Clinical Operations, Clinical Affairs, Medical Affairs, Research, Drug Development, Quality, Regulatory Affairs, and Biostatistics. Below are job descriptions for select positions.

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Regulatory Affairs

A strong Vice President of Regulatory Affairs can make a significant contribution to a company’s long-term financial success. The VP should be able to think strategically about the development pipeline for the company and assess which products are most likely to move through the regulatory process efficiently. The VP should be able to develop a tight timeline and coordinate the activities of all departments towards achieving a high-quality (defined as first time acceptance) and on-time submission. The VP should know regulatory road maps, such as for orphan diseases, which will speed up the clinical trial cycle, the regulatory process and garner more government resources. These things save the company significant money, not usually realized until the end of the regulatory approval process. Read the full job description for a Vice President of Regulatory Affairs.

 

Drug Safety

A strong Head of Drug Safety can make a significant contribution to a company’s long-term financial success. They review individual safety reports beginning in Phase II and contribute to Phase III safety sections of regulatory applications. They set up and run safety and pharmacovigilance operations if none exist, most likely using cloud-based systems popular in the drug safety community. An outstanding Head of Drug Safety will keep operations lean until their clinical-stage company is sold, at which point safety operations will be folded into the acquiring company and it’s software systems. These things save the company significant money, not usually realized until the end of the regulatory approval process. Read the full job description for a Head of Drug Safety.

Quality

In the absence of a Vice President of Quality, the President or CEO of a company becomes the chief jail-able officer for issues related to poor quality. A strong Vice President of Quality makes a measurable contribution to a company’s financial success. Generally, business contributions can be measured by the CFOs office because improvements in quality result in a reduction of costs, reduction of waste or increase in production. Improvements in the end product also contribute to the value of the brand. The VP of Quality should be able to work externally with suppliers, customers and regulators as well as internally, especially with manufacturing and finance. Read the full job description for a Vice President of Quality Assurance and Quality Control.

Clinical Operations

The Vice President of Clinical Operations serves as the nexus of your studies, especially phase 3 studies. The VP of Clinical Operations steers your team to avoid the potential pitfalls below and avoiding costly rework of studies. For example, FDA can and has required companies to repeat Phase 3 studies for mishaps. With an average price tag of over $200 Million for a Phase 3 studies, strong VPs of Clinical Operations pay for themselves by avoiding mishaps and insuring your studies run smoothly and on time. Read the full job description for a Vice President of Clinical Operations.

Medical Affairs

The Vice President of Medical Affairs makes a significant contribution to their company’s financial successes by opening doors for sales people, which leads to increased revenues. They develop relationships with key opinion leaders (KOLs), including doctors, nurses and payers. This shapes the way the product is labeled, marketed and paid for. The Vice President of Medical Affairs should be able to think strategically about how to educate medical personnel and payers on the value of the product and identification of consumers who will benefit most from the product. Read the full job description for a Vice President of Medical Affairs.

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