A System of Leadership for the 21st Century

Lessons from Theodore Roosevelt

by David Markovitz
President and Founder - GMP Training Systems, Inc.

One hundred years ago, the first federal regulations affecting the Life Sciences industry were enacted. This was an era that saw the United States government take an active role in protecting the consumer. Both the pharmaceutical industry and the processed food industry were new and growing rapidly at the birth of the 20th century.

The past one hundred years has seen tremendous strides in health care and life sciences. Today, innovations and new ideas are bursting forth faster than ever before. Product life cycles are shortening. Competition from around the globe is more intense than ever. The baby boomer generation is aging, and putting relentless pressure on the life sciences industry for solutions, preventions, and cures for all sorts of maladies.

The Pressures to Change

The Food and Drug Administration is now examining our systems of control and our systems of management. In February of 2002, FDA implemented a systems approach to inspections for the pharmaceutical industry. They have identified six overall systems to be managed effectively. These are: Quality system, Facilities and Equipment system, Materials system, Production system, Packaging and labeling system, and the Laboratory Control system. The FDA makes it clear that management is responsible for the development and upkeep of these systems. In the Medical Device and In-vitro Diagnostics industries, FDA has identified seven systems of control. They are: Management controls, Corrective and Preventive action, Design controls, Materials controls, Records, Documents, and Change controls, Equipment and Facilities controls, and Production and Process controls.

In August 2002, the FDA announced GMP’s for the New Millennium, a science and risk-based approach to product quality regulations incorporating an integrated quality systems approach. They’ve identified and integrated the following principles into this new initiative:

• Risk-based orientation.
• Science-based policies and standards.
• Integrated quality systems orientation.
• International cooperation.
• Strong Public Health protection.

This and other new initiatives no doubt will put even more pressure on the Life Sciences industries to perform at increasingly higher standards. It is becoming more difficult to successfully lead and manage an enterprise in the life sciences arena.

Looking to the Past

The answers to sustaining a healthy and thriving enterprise may just lie in our past. One hundred years ago a remarkable man, Theodore Roosevelt, held the Presidency. He was President of the United States from 1901 to 1909. Theodore Roosevelt, enshrined on Mt. Rushmore, is considered by historians to be among the top five Presidents in terms of effectiveness and leadership. This article examines Roosevelt’s leadership philosophy and how we can apply his lessons in today’s competitive world.

Roosevelt’s influence was felt long before he became President. He was a New York State Assemblyman while in his early 20’s, served as Civil Service Commissioner for two Presidents, was President of the New York City Board of Police Commissioners, Assistant Secretary of the Navy, a Colonel in the United States Army, and Governor of New York. It was in 1898 during the Spanish American War that Roosevelt got his first inkling that there were problems in the processed food industry. In the spring of 1898, the battleship USS Maine blew up in Havana harbor. The United States declared war on Spain. Roosevelt resigned as Assistant Secretary of the Navy and, along with Colonel Leonard Wood, formed the 1st US Volunteer Cavalry. The press dubbed them the Rough Riders. After training near San Antonio, Texas, the Rough Riders took trains to Tampa, Florida, where they embarked on ships taking them to Cuba. Once there, Roosevelt led the Rough Riders up Kettle Hill, then San Juan Hill, thus ending Spanish Rule in North America. In 1899, Roosevelt documented his experiences in a book entitled The Rough Riders.

Describing the voyage from Tampa to Cuba, Roosevelt said, “The travel rations which had been issued to the men for the voyage were not sufficient, because the meat was very bad indeed; and when a ration consists of only four or five items, which taken together just meet the requirements of a strong and healthy man, the loss of one item is a serious thing. If we had been given canned corn-beef we would have been all right, but instead of this the soldiers were issued horrible stuff called ‘canned fresh beef.’ There was no salt in it. At the best it was stringy and tasteless; at the worst it was nauseating. Not one-fourth of it was ever eaten at all, even when the men became very hungry.”

Eight years later Roosevelt occupied the White House when Upton Sinclair wrote his landmark book, The Jungle. Sinclair’s exposé on the filth and contamination in the meat processing industry rocked the nation. Roosevelt, being a voracious reader, obtained an advance copy of Sinclair’s book. One can picture Roosevelt slamming down the book, and shouting, “AHA! Now I know why that ‘canned fresh beef’ was so horrible.” After corresponding with Sinclair, Roosevelt ordered Secretary of Agriculture James Wilson to get to the bottom of this matter. An investigation was conducted and a report filed with the President. Roosevelt used that report to move through Congress the long-stalled Pure Food and Drug Act and the Meat Inspection Act. He signed both Acts into law on June 30, 1906.

Dr. Harvey Wiley was the Chief Chemist in the US Department of Agriculture when the Pure Food and Drug Act went into effect on January 1, 1907. He thus became the first Commissioner of what today is called the Food and Drug Administration.

Roosevelt Takes Charge

As Vice-President in 1901, Roosevelt was thrust into the Presidency upon the assassination of President William McKinley. With the country reeling from an anarchist’s action in gunning down the President, Roosevelt was quick to visibly assume the mantle of power. He was a man of action, and he didn’t take long to strengthen the power of the Presidency. It was Roosevelt who coined the phrase, “Bully pulpit,” which is still in use today. He believed strongly in leading by example. He knew that, especially as President, people would watch him to see if his actions were consistent with his words. This authenticity helped him achieve everything he was able to accomplish as the 26th President of the United States.

Leadership, as embodied by Theodore Roosevelt, is a system. There are several parts to how he led and managed; yet they are closely woven together as a system. It is difficult to examine any single element of his leadership method without seeing how it needs the other elements present to make it succeed. Yet, to learn from this great leader, we’ll examine separately those elements that comprise the Roosevelt System of Leadership

Creating and Communicating a Vision

Roosevelt had a vision that the United States become a leading world power. The country in 1901 was still recovering from the Civil War. The United States was not recognized as a leading world power by the leading powers of the day, mainly European nations. Roosevelt knew he could bring the United States onto the world stage. And he also knew that doing so would require the support of the American people. He was likely the first President who used the Press to his advantage to get that support.

Roosevelt felt that a canal through the isthmus of Panama was critically important in achieving the aim of world power and respect from the world’s leading nations. First, it would reduce the cost of shipping goods from coast to coast, and second, and most important to Roosevelt, was that it would enable the US Navy to move between the two great oceans with greater dispatch. In his quest to get the canal built, he encountered many critics and adversaries within Congress. After leaving office, he said in 1911, “I am interested in the Panama Canal because I started it. If I had followed conventional, conservative methods, I should have submitted a dignified paper to the Congress, and the debate would have been going on yet, but I took the canal zone and let Congress debate, and while the debate goes on the Canal does too.”

When Roosevelt took office in 1901, the United States Navy was the fifth largest in the world. For Roosevelt, this wouldn’t do. A leading power must have a large Navy, and he pressed Congress to fund a Navy that was second only to Great Britain by the time his term as President ended in 1909. He sent the entire fleet, sixteen battleships dubbed the Great White Fleet, around the world to call in every major port of the world. This voyage sent a resounding message to the entire world that the United States was now a force to be reckoned with.

Lesson Number One – Create and Communicate a Vision

Develop a vision for your company, your division, or your department. Those people working in your enterprise should know exactly what it is they’re being asked to achieve. An effective leader will not only develop a clear vision, but also communicate that vision to everyone clearly. Posting a memo or sending a broadcast e-mail message is NOT an effective means of communicating a vision. One must do something big, something dramatic, to get people’s attention. And the message must be repeated over and over again. In just about every speech he delivered throughout his Presidency, Roosevelt reminded the citizens of his vision for the country. It was his relentless pursuit, his zealous drive, which caused people to support him.

Generating and Sustaining Trust

Trust and integrity were critically important to Roosevelt’s success throughout his career. People will trust you if you prove that you are competent. People will trust you if you care about them. People will trust you if you give them the opportunity to speak up and raise differing points of view, and then listen.

When Roosevelt assembled the Rough Riders in 1898, he assembled a motley crew of eastern intellectuals, his friends from his days at Harvard, Western roughnecks from his days in the Dakota territories, athletes (a champion polo player), writers, ranch hands, Native Americans, and others. He developed them into a crack Cavalry unit. He knew that he alone didn’t have the military experience to accomplish this. He arranged for Col. Leonard Wood, an accomplished military man, to take charge, and Roosevelt assisted him as Lt. Colonel. He knew that he did not have the military competence at that point, having only served in the New York state militia. But he also knew that he had a capability to communicate effectively with this diverse group of men. So together, Col. Wood and Roosevelt were unstoppable. They earned the trust and respect of their men.

Roosevelt was a man of his word. In 1904, he was elected President in his own right, in a huge landslide victory. After his election he stated that he would not run again in 1908. He cited the fact that he had been President for all but six months of his first term, and that he would respect the precedent set by George Washington and only serve two terms. Four years later, after thoroughly enjoying the job as President, he regretted making the statement limiting himself to two terms. But he lived by those words and did not seek the nomination in 1908. That’s called integrity.

Lesson Number Two - Generating and Sustaining Trust Among Those You are Leading

People expect their leaders to be competent. So the first element here is to gain the competence to do the job. This may require hard work. Roosevelt once said “I have never won anything without hard labor and the exercise of good judgment and careful planning and working long in advance.”

Congruity is important here as well. Your actions should match your words. Ethical and honest behavior can be contagious. Leaders set the tone for those they are leading. This is especially important in the Life Sciences industries, where our customers are comprised mostly of patients, whose very lives may depend on the decisions made and the actions taken by those in our company.

Competency, congruity, integrity, and trust are also critical when it comes to building effective teams. Building an effective team takes time and takes some nurturing. This nurturing process helps in achieving a shared commitment to the vision as well. Building an effective team often means hiring people more talented than you.

Conveying hope and optimism

Upon becoming President, Roosevelt inherited a country that was rife with disputes between Labor and Capital (Big Business). Monopolies were forming, stifling competition. The economy was stagnant. Shortly after becoming President, he said, “I preach the gospel of hope. Our nation is one among all the nations of the earth which holds in its hands the fate of the coming years. We enjoy exceptional advantages, and are menaced by exceptional dangers, and all signs indicate that we shall either fail greatly or succeed greatly. Here is the task, and I have got to do it.”

Roosevelt was always looking to the future. He believed in America’s optimistic dream. But he also knew that achieving greatness meant working hard and overcoming fear. Growing up was a challenge for Roosevelt, as he had asthma, and a weak, sickly body. Roosevelt struggled to keep up with all the physical activities of youth, and was even called “Four-eyes” by the neighborhood children, as he wore glasses beginning at a very young age. As he entered his teens, his father challenged him to build his body and bought athletic equipment to help him achieve a stronger body to accompany his robust mind. In his twenties, as he tried his hand at ranching in the Dakota territories, he was called “Dude” and “Four-eyes” by the rough and tough cowboys out west. It was from these experiences early in life that Roosevelt developed the courage to overcome fear and move forward even in dark times.

Lesson Three - Conveying Hope and Optimism

In these times of worldwide economic and political pressures, people do respond positively when the leader conveys hope and optimism. The old adage, “Is the cup half empty or half full?” resonates still today. Those leaders who take the half-full approach and convey that approach to those around them tend to fare better during the tough times.

A leader has the responsibility to get people in the proper frame of mind, to get psyched up, to move forward. A leader who sees good ahead will have more followers than one that wallows in despair. Communicating a positive message, particularly in tough times, must be repeated over and over. The optimistic outlook is contagious.

Tough times may require that the vision be adjusted, or modified. An effective vision should be achievable given the existing resources and conditions. Otherwise, the optimistic look ahead may just be perceived as unattainable, thus causing people to go through the motions, and not really supporting and working toward achieving the aim.

Focus and alignment on achieving the vision is important. Consider the following diagram. The big arrow can represent the vision of your company, your division, or your department. The smaller arrows within the big arrow can represent different divisions within the company, different departments within the division, or different people within a department. Which organization, A or B, do you think will move forward faster?

A leader’s job is achieving the alignment displayed by Figure B above. This requires constant communication and attention.

Taking action, taking calculated risks, and having a sense of adventure

Roosevelt was a man of action. He liked facts and wanted to see for himself. In 1980’s management literature, the term “management by walking around” was popularized. Theodore Roosevelt practiced that a good eighty years before it became the latest “management fad”. He was the first President to visit a foreign country while President, when he went to Panama to check on the progress of the Panama Canal.

Roosevelt said, “Life is a great adventure, and you cannot win the great prizes unless you are willing to run certain risks, unless you are willing to pay certain penalties.” Roosevelt did take great risks, but they were always calculated risks. He used fearlessness not as recklessness, but with a calculated eye. He understood the risks and possible penalties before he embarked on an initiative. He also said, “Be practical as well as generous in your ideals. Keep your eyes on the stars, but remember to keep your feet on the ground.”

He saw the great value of air power for the military, and awarded the Wright Brothers the first contract for aircraft for the Army. He was criticized by his political foes for this folly. Looking back 100 years later, we can see that he was right.

After being out of the White House for four years, he felt that his successor, William Howard Taft, had betrayed him by not continuing several of his policies, particularly in the area of the conservation of natural resources. He campaigned for the Republican nomination in 1912, but Taft had by this time maneuvered his loyalists into the key party positions. Taft’s political operatives wouldn’t seat Roosevelt’s delegates at the convention. Rather than acknowledge defeat, Roosevelt formed the Progressive Party, better known as the Bull Moose Party, and ran for President on that ticket. Roosevelt wasn’t one to let obstacles get in his way. He always had a back-up plan. Another quote he used frequently is, “It is hard to fail, but it is worse never to have tried to succeed.”

Lesson Number Four - Taking Action, Taking Calculated Risks and Having a Sense of Adventure

A bias toward action is a key requirement for an effective leader. Planning is necessary, yes, but at a certain point action must be taken. We don’t always, if ever, have the luxury of waiting for all the facts to be in, for all the confirmation, for all the study group results to be in, before taking action. Achieving great accomplishments requires a certain degree of risk. The winners are those who can sort through all the data and pick out the relevant facts that indicate whether success is achievable. Winners also have the capacity to overcome obstacles that get in the way of progress.

Optimizing Your System of Leadership

As we now face FDA’s System Approach to Inspections of our facilities and the GMP’s for the New Millennium, it behooves us to examine and optimize our System of Leadership.

Taking heed of Roosevelt’s Four Lessons for Effective Leadership can help you become a better leader and a better manager yourself. Examine how this system of leadership and management can be integrated into your personal style of leadership.

Another important quote from Theodore Roosevelt is, “Success, the real success, does not depend upon the position you hold but upon how you carry yourself in that position.”

Throughout his career, Roosevelt always focused on the task at hand. He always looked to do his very best in whatever position he currently held. He believed that rather than seeking success, a leader should seek to deserve success. Every office he ever held he quite sincerely believed would be the last he would hold.

As the challenges continue to mount in reaching the top of your industry, and working to stay at the top, these lessons from Theodore Roosevelt can be invaluable. Strive every day to incorporate these lessons into your personal plan and you just might reach your personal pinnacle of success.

David Markovitz is the President of GMP Training Systems, Inc., a consulting and training firm specializing in helping the Life Sciences industries.  David is the author of Becoming the Best: Making Optimization Happen, and is the co-author of GMP Makes Good Business Sense, The Team Process Improvement Workbook, The Innovation Resource Handbook, and the 212 Optimization Tips booklet. 

David has developed a one-of-a-kind innovative approach to teaching the history and evolution of FDA regulations and the leadership and management skills required to maintain compliance.  David brings Theodore Roosevelt Back to Life in presentations specifically tailored for the Life Sciences industry.  Many companies have invited David to share this unique uplifting experience with their employees.

With over twenty-five years experience with SmithKline Beckman, Nutrilite Products, Organon Diagnostics, and a division of Johnson and Johnson, David is well known for helping pharmaceutical and medical device companies use GMP compliance to improve their overall performance, productivity, and profits.  He is the creator of the GMP Ready-to-Use Training System™, a training system developed for in-house GMP trainers, supervisors, and team leaders to use.

Learn how David can help your company achieve higher levels of performance by going to www.GMPTrainingSystems.com and www.TheInnovatorsWay.com

You can reach David at 714-289-1233 or at David@GMPTrainingSystems.com