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Management Consulting for Clinical Research

— W&A Staff will be posting news, observations and links.  

Needham, MA, July 1, 2014–

Waife & Associates, Inc., change management consultants in biopharmaceutical clinical research, has opened a Twitter feed, @WaifeAssoc, which is now active. Recognizing the many media channels that professionals are using today to stay informed and spread observations and discussions, W&A Associates will join this dialogue and plan to point out interesting industry developments, upcoming events, and observations on how W&A can help research improvement in pragmatic ways. Please join us!

Needham, MA, May 21, 2014 – The first annual Benjamin and Sholom Waife Memorial Scholarship in Scientific Journalism was awarded at Needham, Mass. High School Class Day ceremonies today. The scholarship, created by Waife & Associates, Inc., supports collegiate studies toward a career in writing or journalism about science and medicine. The annual award’s first recipient is Olivia Korostoff-Larsson, selected by the faculty of Needham High School.

 

The Scholarship is in memory of Benjamin Waife (1895-1972) and his son Sholom O. Waife, MD (1919-2011). Waife & Associates, Inc. is based in Needham and was founded by Dr. Waife’s son, Ronald S. Waife. Benjamin Waife, writing under the pen name B. Z. Goldberg, was a newspaper editor and columnist for over fifty years for New York and Israeli newspapers. For most of his career he was editor of Der Tog, one of the two main Yiddish newspapers in New York City in the 20th century.  He earned one of the first psychology PhD’s from Columbia and wrote two books, in addition to his weekly column which appeared in various newspapers until his death.

 

Dr. Sholom Waife continued the family writing heritage by combining it with his medical profession. He started one of the first in-service hospital CME Programs, at Philadelphia General Hospital, developed an award-winning series of textbooks while at Eli Lilly & Co. which were distributed to all US medical school graduates, wrote a column for the Physicians Bulletin, co-founded the American Journal of Clinical Nutrition, and was an early national officer of the American Medical Writers Association (AMWA).

 

Both Benjamin and Sholom Waife dedicated their professional lives to clarity in writing and using the written word to make complex subjects easier to comprehend. The Scholarship is intended to further these principles, in these times when science and medicine are increasingly affecting our daily lives, yet are moving further from common understanding.

 

Waife & Associates, Inc. will be awarding this scholarship annually. The company provides management consulting services to biopharma organizations conducting clinical research.

“Steering Committees are models of the law of unintended consequences”

We commonly assume that the involvement of senior executives in a project will improve the performance of that project. To that end, we form “steering committees” of such executives to, presumably, steer the project to its shining destination. Too often, instead of steering, these committees are little more than backseat drivers: they can’t see the road ahead, don’t know the route, don’t work the controls, and are lulled to sleep in the moving car. Like the classic backseat drivers, this position doesn’t preclude them from shouting directions and complaining about the ride – even to the point of hoping that the car will just turn around and go back home.

 

Unintended Consequences

 

Steering Committees are models of the law of unintended consequences. Do we think we might co-opt our executives into supporting our project by forming an executive committee for them to sit on? Be careful what you wish for! Depending on your company culture and individual executive personalities, your steering committee may turn into a new venue for inter-department conflict. It may draw unwanted, uninformed attention to a project the members did not know about and do not support. It might be the perfect forum for micromanagement. It is commonly the ideal mechanism for stalling, rather than enhancing, decision-making.

 

Even if you avoid these dire unintended consequences, a steering committee is almost guaranteed to delay your timetable, if for no other reason than since you created the committee, by definition it has to meet. And as an executive committee, by definition, it is very hard to get these folks in the same room at the same time on any regular interval. This leads to all middle managers’ bête noir – executives calling in to committee meetings from their scratchy cellphones from their car or another continent, or both. As we know, as the committee meeting reaches a critical decision point, the cellphone call is guaranteed to drop – perhaps conveniently, if avoiding a decision is the goal.

 

Overall, the common experience of those living with steering committees is their pure unpredictability. Having formed one, you are stuck with them – you cannot ignore them, hurry them, or argue with them. By forming one, you’ve created a new workload for yourself with unclear benefit.

 

The Value of a Steering Committee

 

A steering committee might be useful at three distinct points in a project:

1) In the very beginning, when money and staff resources, departmental alignment, the will to change and priorities all need to be marshaled.

2) At the very end of your project, to dole out appropriate praise to those deserving staff, and to lead a serious lessons-learned effort that generates meaningful knowledge for the next project.

3) During a particularly dire crisis midstream, when only executives can decide about a change in direction, investment, cancellation or expansion, often due to circumstances external to the project that the executives are in a unique position to know about and understand.

 

Each of these circumstances plays to the precise strength and purpose of executive guidance. They can be critical to your project and the investments being made. The trick is how to anticipate whether and when you will need this important assistance.

 

These three circumstances are at best discrete moments. The beginning and end points of your project may be benign and easily handled. There may be no crises at all. In which case, if you are preparing for monthly steering committee meetings, and living with the results, you are paying for insurance you may never need.

 

Other than these three points in time, what the steering committee most needs to do is to stay out of the way. One way towards that is to not schedule regular steering committee meetings on some artificial calendar-based schedule. Having regular arbitrary meetings only invites and legitimizes the backseat driving behavior. If a group meets regularly, eventually they will feel obligated to do something, much like an auditor feels obligated to find something wrong. Nothing is more dangerous than a committee looking for a purpose.

 

An Alternative

Why are we worried about the impact of a steering committee on decision-making? This is both the heart of the frustration and the solution to the problem. We are mixing up “steering” and “deciding”. You need not automatically abdicate authority to a steering committee because of its name or the rank of the members. It is precisely this abdication that makes this discussion so important. Stalled or misguided decision-making undermines the hard work of clinical development professionals everyday. You hurry to a deadline, only to find that people are not ready for the fruits of our labors. Only the most knowledgeable and best informed staff can make use of your work, and decide what and when to move forward.

 

In all but the handful of circumstances described above, why do you need a steering committee? Perhaps “steering committee” is the wrong term – you may not need to be “steered” at all, but rather advised, or helped. Can a project or a trial use the advice of senior executives? Can you use their help in getting cooperation from their peers, additional funds, or scientific guidance? Absolutely. But clearly that is not “steering”. Indeed, perhaps we who are running the project should be in fact steering the steering committee – being alert to how they can help, and when.

 

We are the ones at the wheel, foot on the gas, eyes on the road. You may have even been down this road before, or one very similar to it. You have passengers who can help with the trip, and we welcome executives to come along for the ride. They will enjoy it and we will learn from them. But leave the driving to us.

“Our chief want is someone who will inspire us to be what we know we could be.”
― Ralph Waldo Emerson

 

As I write this, the US Government is shut down. One cannot help but think about leadership at a time like this. We look to our leaders for many things, but most importantly, we want to be led. We want to confidently place our trust in our leaders – political, religious, business, familial – to take us somewhere better than where we are; somewhere safe, positive, even inspiring. But sometimes it feels like the only thing that is consistent in our work is a lack of leadership.

Far too many of our R&D leaders have feet of clay. There is something about scientific and academic cultures that pre-dispose to passive, cautious, uncommunicative, and untrained leadership. This begs the question of how these men and women became senior management in the first place. Perhaps those that hired them possess similar traits and are hiring in their own image, or that our workplace cultures have grown to reinforce passive leadership. Whatever the reason in your organization, the effect is damaging.

 

The Clay in the Marble
“Consensus: The process of [searching for] something in which no one believes, but to which no one objects.”
― Margaret Thatcher

Noticing leaders with feet of clay is literally as old as the Bible (see the Book of Daniel). We see signs of clay-footed leadership in clinical research every day. There are many common examples:
• An executive who shields him/herself with an administrative assistant whose job it is to prevent appointments.
• An executive who arrives late to meetings, leaves early, and says nothing.
• Or the opposite – an executive who calls a meeting of the “team” to discuss even the most minor and obvious decisions. (An oxymoron candidate: “leadership team”).
• Most commonly, the feet of clay are revealed simply by the executive who does not respond – to emails, to direct questions in meetings, to any requests for follow up.
• The insidious example: the ones who impatiently drive a group into a new initiative, and once it is launched, they disappear, on to the next.
• Those who only manage upwards (i.e., to their bosses) – these you never see, because they are spending all of their time in their bosses’ meetings, or trying to get one, so that the dialogue of fictional progress can churn without interruption.
• The masters of delay, who have learned that if they wait long enough, the decision will be made for them, or likely become moot.
• And the preservers – the system is what promoted me to this amazing position, I am not going to rock the system.

 

A Leader Fully Cast
“The day the soldiers stop bringing you their problems is the day you stopped leading them. They have either lost confidence that you can help them or concluded that you do not care. Either case is a failure of leadership.”
― Colin Powell

There are simple, but oh so difficult, answers to this failed leadership. Leaders must heal themselves, or seek the training, to do six things, all day, every day:
Listen, Ask, Decide, Explain, Point, Sustain.

• Listen: Well, first, leaders have to make themselves available in order to listen. Indeed, they don’t have to wait, they can go out to their staff and sites and listen. When a good leader is listening, they are applying their experience and judgment to what they hear, while reinforcing what I will call “controlled openness”, i.e., an openness with sincere limits.
• Ask: Having listened, the effective leader will ask questions, again based on their experience. Not for the sake of showing off that they are listening, but to get at the information that he or she needs, which may be missing, in order to…
• Decide: The leaders we need in research need to decide the issues we have brought to them – quickly, clearly and consistently – having gathered the essential information. If we wanted our leaders to stall, we could easily procrastinate on our own without them.
• Explain: Many research leaders may think that they do listen, ask and decide, but after the decision is where the more serious breakdowns occur. Why your leader made a decision should be clear, and appropriately (not necessarily widely) communicated, with as much frankness as possible. The reason for the decision should be put in context – how the decision fits with company and departmental strategy, with personnel strengths, with budgets and resources. Decisions are a terrific opportunity to reinforce communication to staff on all of these guiding contexts.
• Point: Leaders have a permanent daily role, besides decision-making. We look to leaders to point the way – where are we going and why, what to watch our for, what questions are still to be answered, where there may be pitfalls and opportunities.
• Sustain: Last but not least, leaders must sustain these positive leadership qualities, day to day, month to month. Too often we hear from leaders only in times of crisis or predictable celebration. A stern warning on study timelines, vendor oversight or enrollment shortfalls is followed up with silence, undermining any steps for improvement.

 

Re-sculpting
It’s very challenging to improve on ineffective leadership from below. If they won’t engage, how do you even have a constructive conversation? You can try to appeal to self-interest, which will vary by personality – are they motivated by money, power, influence, ego? To say they are motivated by scientific excellence is both a truism and insufficient. A more likely path to encouraging, or forcing, improvement is top-down, but isn’t that how we got into this situation in the first place? An ineffective leader is likely the product of a culture that, at least in the upper reaches, is encouraging caution, “getting along”, “team playing”, and “good news” communication. It is precisely this company culture that has to be changed by, yes, an effective leader – bold, decisive, inspiring.

 

I suspect that we dream about such leaders from birth. We are drawn to them, we seek them, we follow them. Some of us become them. We don’t all need to be leaders, but someone has to. It is never too late, or too early, to find and nurture them.

Waife & Associates Adds New Senior Associate in Boston

— Former Millennium executive strengthens W&A depth and increases Informatics expertise.

Needham, MA, February 3, 2014— Waife & Associates, Inc., change management consultants in biopharmaceutical clinical research, announced today it has added a new Senior Associate, Siegbert Kloos, to its staff. Mr. Kloos comes to Waife & Associates, Inc. (W&A) from Millennium: The Takeda Oncology Company, where he was most recently Senior Director, Medical Informatics, Strategy and Operations.  Mr. Kloos brings a deep and expert background in both clinical research and medical informatics, a critical intersection for Waife & Associates’ clients.
Based in Boston, Mr. Kloos has nearly thirty years’ experience in clinical research, beginning as a Research Fellow at the University Hospital in Bonn, Germany, followed by five years at Padcom Clinical Research, a CRO (clinical research organization) and developer of early innovative electronic data capture (EDC) software. For nine years, he worked at F. Hoffmann-La Roche in various Informatics capacities in Palo Alto and Basel, and then as Director of Development Lifecycle Systems at Genentech in South San Francisco. Mr. Kloos joined Millennium in 2008, where he initially designed and implemented the Informatics strategy for all departments in clinical development, including Translational Medicine and Pharmacovigilance in addition to Clinical Operations and Biometrics. Later, he created the Strategic Project Management Office, rebuilt the Medical Finance function, and oversaw Medical Business Operations.

 

“We are very pleased to add Siggi to W&A,” said Ronald S. Waife, President, Waife & Associates, Inc. “He deepens our long expertise in Informatics, which underpins all clinical development improvements. He has directly and successfully contributed to the management of global enterprises, encompassing Japan and China as well as the US and Europe. In addition, his extensive exposure to and involvement in the business side of development operations is the perfect complement to our process engineering focus.”

 

Mr. Kloos has been active in the DIA and ACDM, as well as several inter-company working groups. Mr. Kloos was Chair of the Oracle RDC Focus Group for five years, and the MACRO User Group for four years. He has published more than two dozen papers in scientific journals since 1985.

 

Mr. Kloos earned his MSc in the Medical School of the University of Bonn, and studied Biomedical Engineering at the University of Giessen, Germany.  He has received advanced training at the Harvard and London Business Schools and the Takeda Leadership Institute. He is fully bilingual in English and German.

 

Mr. Kloos can be reached at kloos@waife.com or +1 650 888-1758. To learn more about Waife & Associates, Inc., visit www.waife.com.