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Industry experts say the technical competencies of drug development have to be combined with the softer skills of change management and leadership ability. R&D leaders will have to work in global teams to manage the output from their partners. This will require highly trained technical specialists who have strong interpersonal and communications skills. Working in multicultural, multidisciplinary teams, experts say, makes leadership development even more critical since companies have to motivate a group of people to work together and be focused in the same direction as a dedicated resource to solving a problem. Last year, Heidrick & Struggles and the Economist Intelligence Unit published a Global Talent Index that evaluated the current state of global talent. The survey found that very few companies across many industries have high ly effective teams at the top. “A true team works cooperatively, shares information immediately, knows how to communicate with each other, and knows how to solve prob lems as a group,” says Mike Laddin, president of LeaderPoint. “It’s up to the leader to build that team by providing clarity about what’s important and what needs to be accomplished and how progress is going to be measured.” As the world in general, and drug development in particular, becomes more glob al, it will be important for managers to understand not just how to communicate and collaborate with people in the business sense but how to collaborate and communi cate in a cultural sense as well, says Daniel Hiltz, Ph.D., director of global learning and development at Kendle. “This is an important part of employee engagement, which is a big issue,” he says. “We know that employee engagement is tied to employee satisfaction and employee retention. We know this is a big issue in the United States and suspect this is probably the case in other countries as well.” Terri Cooper, Ph.D., principal in the lifesciences practice of Deloitte, says the demand for highly qualified leaders in the research arena will only increase. “Ultimately, one of the biggest challenges companies have right now is their ability to increase Just as the world of pharmaceutical research and development is changing, so too are the training and educational needs of professionals involved in R&D. The challenges faced by a global industry that increasingly partners with outside research teams require managers and leaders to have a whole new set of skills and competencies. BY DENISE MYSHKO The Softer Side of R&D An increasingly global environment for drug development is CHANGING HOWTEAMSWORKTOGETHER. Research and development leaders will need to hone their skills for managing people across cultures and across teams. 0408 Layout FINAL MW 3/21/08 11:44 AM Page 50 51 PharmaVOICE Ap r i l 2 008 “The difference between someone who is good tech nically and someone who is an outstanding leader usu ally has to do with the soft er leadership skills in terms of their ability to influence others and problem solve effectively with groups of people,” he says. Experts say, in general, the training and development of future R&D leaders is inconsistent and scattered. While many companies are putting in place learning opportunities, often missing is the recognition that leadership devel opment is something that happens over time. “I distinguish between training and development,” Mr. Laddin says. “Training is an event. Development is a process that is often life long. Oftentimes as a Band Aid, we put in place a training event and hope people get it. People learn to lead by leading over time and by being placed in a variety of situations.” According to a recent ESI Inter national survey conducted across 12 different industries, the skill gaps include critical thinking, strategic think ing, innovative or creative thinking, tactical thinking, and analytical thinking. “Another gap identified was a lack of busi ness acumen, being able to connect work, what ever it may be, to the larger picture and align ing with organization goals, strategies, and objectives,” says Julie Zinn, executive director of project management and the business skills program at ESI International. “Another big skill gap was communication know how.” Working in TEAMS Dr. Cooper says the outsourcing of clinical trial programs has changed the roles of many individuals within research and development. “We are observing that the individuals who were accustomed to running study pro grams and managing their own internal CRAs are lacking the skills to manage an external CRO or other service provider,” she says. “It is a challenge for individuals to manage these external partners. Quite often there seems to be a lack of trust and the contracts are not set up accordingly. So rather than actually realiz ing the benefits of outsourcing, what often happens is that there is a huge duplication of effort because the roles and the responsibilities have not been clearly defined. As a result, the internal clinical development team will redo much of the work of the CRO.” From a training perspective, she says, there needs to be a great deal more instruction around contract negotiations, working in col laboration with external parties, and having people manage and report on the deliveries expected from an external party. Alice Jackson, CEO and founder of Lifetree Clinical Research, says the ability to work in teams is critical. “People have to work in teams, not just within their own companies but also with clients and thirdparty suppliers, such as labs, medical writers, and so on,” she says. “Putting together a budget and negotiating with phar maceutical companies are challenges.” Bev Hudson, VP and general manager of the research services group at Medpoint Com munications, says managing a team requires a the productivity of clinical programs,” she says. “Many of the large pharmaceutical com panies are trying to expedite their clinical pro grams. Unless they can effectively manage external resources and can find highly trained individuals who can run their programs, they’re not going to realize the productivity gains they’re looking for.” The risks and the challenges that researchers face are large but these can be addressed by effective leadership, says Fred Hausheer, M.D., CEO of BioNumerik Phar maceuticals. “The strongest people who work in research — the ones who persevere — are the ones who are inter ested in solving development problems for the good of patients,” Dr. Hausheer says. “The complexity of the prob lems is increasing very rapidly. We’ve had an explosion of tech nology that relates to the human genome and potential genes that can be targeted by drug therapies, by mono clonal antibodies, and by vaccines. The only way challenges of this magnitude can be solved is by leadership.” Such opportunities, he says, are creating a need and demand for those in research who can lead and who can develop future leaders. “The best leaders are team builders, and they also develop more leaders,” Dr. Hausheer says. “At the same time, they work on growing the people in the group to become better leaders.” Research organizations are looking at what their core competencies are, as well as what they need from an educational perspec tive to help people understand the softer side of leadership, such as change management and working effectively in teams, says Tim Bray, VP of global learning and development at Quintiles Transnational. R&D training The burden for training those in research is falling to the community colleges and the universities, and maybe that is where it belongs in each community. JEANMARIE MARKHAM Clinlogix New global leaders MUSTHAVE VERY SPECIFIC COMPETENCIES. Heidrick & Struggles 0408 Layout FINAL MW 3/21/08 11:44 AM Page 51 52 Ap r i l 2008 PharmaVOICE R&D training high level of skills especially for complex pro ject management. “Most sponsors and CROs are looking for people who can execute projects with a high degree of expertise and be able to manage and lead teams in an environment that can change quickly,” she says. Skills for LEADERSHIP Researchers need to be able translate what happens in the clinic for senior management. They have to understand the technical details, as well as the language of business. They have to be able to help develop a business strategy and then be able to translate that to the objec tives of the research organization. “Managers often assume that as individuals progress in their careers, these types of skills are automatically developed,” Ms. Zinn says. “We take thinking for granted. We take com municating for granted because we do those things all day long. These are soft skills, yes, but they are often the hardest things that we do. These skills can be developed if they are taught in a tangible `hard’ way. It’s important that we provide individuals with a structure and an approach to develop these skills.” Research organizations are beginning to recognize the need to address these types of leadership skills. Quintiles, for example, is working with CRAs to help them to be able to influence the physician or the staff to change something in the process to make sure that the study has quality outcomes. “Frequently when I talk to line managers who manage clinical research associates, they will tell me the difference between an average CRA and a superior CRA is their ability to influence people to change something in the process to achieve better outcomes,” Mr. Bray says. He says Quintiles is beginning to realize an impact from its program. “While interpersonal skills are tough to measure, we do see some positive outcomes with our project managers,” he says. “What customers value about project managers is their timeliness and accessibility, as well as their proactivity when issues arise. We see a strong correlation between engaged employ ees and loyal customers.” Kendle breaks its training programs into two different groups. There is a series of clini cal topics and a series of management and leadership topics. On the clinical side, the company has cur ricula for project assistants, for various levels of CRAs and for project leaders, as well as addi tional programs for global megatrial project leaders. The company also put in place a program, called Leadership 100, in May 2007 for senior level managers to help people at each stage of their leadership career. “We have a series of events that are sched uled on a monthly basis,” Dr. Hiltz says. “The message is that leaders are people who drive change. We’re trying to make sure our leadership understands that it’s their role to make things change. Skills are related to a set of competencies and a set of behaviors that have been mapped and identified in academic settings. We believe that by identify ing the behaviors around leadership, people can be taught to lead more effectively.” For 2008, Dr. Hiltz says Kendle is developing a comprehensive measurement and evaluation strategy to assess the impact of the Leadership 100 program. “Our orientation in 2008 is going to be based on actionlearning concepts; there will Essential Characteristics for a GLOBAL LEADER The complexity, pace, and global platform of today’s business environment demands a special set of characteristics. Apart from heightened requirements in terms of background and experience, the leadership criteria have changed dramatically over the past 10 years. There is now no substitute for global leadership experience. But when looking at the global talent index and the concentration of talent across the globe,one key question emerges:how can one better assess the global leadership capabilities of the various talent pools? FROM A SEARCH CONSULTANT’S POINT OFVIEW THESE ARE THE ESSENTIAL CHARACTERISTICS TO LOOK FOR IN THE NEWGLOBAL LEADER: Having the flexibility to handle these potential paradoxes is the key characteristic of future top executives. Source:Heidrick & Struggles Global Talent Index, Chicago.For more information, visit heidrick.com. MANAGING PARADOXES . Taking a helicopterview and thinking strategically while keeping the focus on operational results . Switching easily between different modes: from longterm thinking to shortterm,and from cost saving to expansion and growth The leadership training that skilled technical professionals receive now is at best inconsistent and scattered. MIKE LADDIN LeaderPoint Business success at the top (and further down the organization) DEPENDSONTHE LEADER PULLING EFFECTIVETEAMS TOGETHER. Heidrick & Struggles INTERNATIONAL LITERACY . Operating in different geographic regions . Understanding the cultural differences of employees and customers . Dealing with ambiguity . Enjoying diversity in a psychological sense 0408 Layout FINAL MW 3/21/08 11:44 AM Page 52 FullService Contract Research Organization CRITERIUM Criterium Inc. is a global CRO — organized around technology — that offers a unique mix of highquality clinical research services, realtime data acquisition and personalized communication processes to manage a trial from initial planning to approval, on time and on budget. At Criterium, who we are, what we do, and how we do it are centered on our service reputation: an uncompromising “Always Delivers” attitude in everything we do. GET TO KNOW US! www.criteriuminc.com PROVIDING INNOVATIVE SOLUTIONS SINCE 1990 NEW YORK / CALIFORNIA / FLORIDA / SOUTH AFRICA / THE NETHERLANDS / INDIA / RUSSIA / ISRAEL Ronny Schnel Executive Director, Business Development and Client Services Knows How to Deliver To learn more about our donor match program for the Clinton Foundation HIV/AIDS Initiative please call 3103777517 or visit our website at www.criteriuminc.com. “Consider it done.” PVad_RS_Criterium0408 3/24/08 12:54 PM Page 1 54 Ap r i l 2008 PharmaVOICE R&D training be specific deliverables that the teams within the Leadership 100 will be expected to deliver on,” he says. Ms. Zinn cautions, however, that before implementing any training, senior manage ment has to align resources with job require ments and what needs to be accomplished. “We recommend that some type of assess ment occurs so managers can evaluate the cur rent state of their workforce, as well as assess the competencies that are required to help an organization succeed,” she says. Distance LEARNING The Internet and other alternatives to tra ditional classrooms have opened up a new world for training. Technologies such as Web casts, Podcasts, and Web 2.0 social network ing continue to shape how and when people want to receiving training. “Global workforces and projects have spon sors as well as clinical service providers think ing about how to extend training to more peo ple around the world for longer periods of time,” Ms. Hudson says. “We’re in the midst of a culture change, moving from what was predominantly a face toface learning environment to a distance learning environment,” Dr. Hiltz says. “We have found that classes that follow the princi ples of sound instructional design of adult learning theory adapt well to the virtual class room environment and they are well liked.” Quintiles has a global learning manage ment system that offers a combination of 650 technical courses available through either classroom instruction or elearning and an additional 2,500 soft skills programs available through elearning. Quintiles has found some success using Podcasting as a learning tech nique; this allows clinical team leaders to pro vide uptodate information to all members of the team. “We find that the clinical monitoring audi ence tends to be fairly young,” Mr. Bray says. “Many grew up with video games and are part of the iPod generation. They want programs that are more flexible where they do not have to sit in front of a computer system.” Experts, however, caution that classroom training is still important, especially for devel oping soft skills. “There are some skills that are better learned in a facetoface environment,” Ms. Zinn says. “It’s important that groups still go through a problemsolving process and see the way the group interacts. This is a good way to generate ideas and evaluate group dynamics.” Partnering for TRAINING Pharmaceutical companies, says JeanMarie Markham, CEO and president of Clinlogix, no longer have formal inhouse training pro grams. “Training is left to the individual,” she says. “People tend to look to organizations such as ACRP and other associations and pro fessional organizations that provide training and education. There also are more universi ties that are entering into the field. Some of the training burden is starting to fall to the universities and community colleges, and maybe that is where it belongs.” Experts say graduate certificate programs — such as the one recently launched by Northwestern University in clinical research and regulatory administration — have value. “There are more of these types of programs because clinical trials have become more com plex,” Ms. Hudson says. “These programs help move different professions forward, they iden tify best practices, and they emphasis safety. More than 40% of Deloitte survey respondents BELIEVETHAT RECRUITING ANDRETAININGTOP MANAGERSAND SCIENTISTS IS A KEY STRATEGY FOR SUCCESS. Deloitte With more complex and global clinical trials, there is a greater need to test and document whether the training was effective. BEV HUDSON Medpoint Communications DR.DANIEL HILTZ Kendle As companies begin partnering or outsourcing across the ocean, it’s even more important to have effective communications skills. JULIE ZINN ESI International We distinguish between management and leadership. The role of a leader is to create new processes and to make changes to existing processes to adapt to the evolving world of clinical research. 0408 Layout FINAL MW 3/21/08 11:44 AM Page 54 PATIENT MESSAGING SOLUTIONS At The Pharmacy Point of Care DIRECT TO PATIENT Identify Patient Candidates: Based on the treated patient’s medication, age, and location. REAL TIME, INTERACTIVE MESSAGING Present Study Opportunity: Present targeted, interactive messages to patients while they are requesting their prescription. ENROLL THE TARGETED PATIENT Timely Patient Referrals: Ateb delivers prequalified candidates to the study site, support program, or call center . Clinical Patient Recruitment . Bioinformatics . Brand Messaging YOUR PRESCRIPTION FOR COMMUNICATING WITH OVER 75 MILLION PATIENTS Contact Sales by phone: 919.882.4935, or by email: firstname.lastname@example.org atebad.QXP 3/27/07 3:49 PM Page 1 56 Ap r i l 2008 PharmaVOICE R&D training Overall, they raise the bar. A mix of academic and onthejob training is highly desired.” Universities help bridge the academic world of research and the world of business so that companies get the latest and the best thinking to run their operations, Dr. Hiltz says. Kendle, he says, has a collaboration with the University of Cincinnati. “Every year, we sponsor two of our employees as scholarship participants in the university’s program, which is a master of sci ence degree in pharmaceutical sciences with a drug development specialization,” he says. “In addition to that, the university offers a certificate program in clinical research, and we have brought those classes in house so our employees can attend classes in our facility and get credit toward a University of Cincin nati clinical research certificate. We view this as a great way to help ourselves and our employees.” # PharmaVOICE welcomes comments about this article.Email us at email@example.com. TIM BRAY. VP, Global Learning and Development,Quintiles Transnational Corp., Durham,N.C.;Quintiles provides a range of services in drug development, financial partnering, and commercialization for the pharmaceutical,biotechnology,and healthcare industries. For more information, visit quintiles.com. TERRI COOPER,PH.D.Principal in the Life Sciences Practice, Deloitte LLP, NewYork; Deloitte provides auditing, consulting, financial advisory, risk management,and tax services. For more information, visit deloitte.com. FRED HAUSHEER,M.D. CEO,BioNumerik Pharmaceuticals Inc., San Antonio; BioNumerik is focused on the discovery, development,and commercialization of novel drugs for the treatment of cancer and cancer supportive care. For more information, visit bionumerik.com. Experts on this topic DANIEL J. HILTZ,PH.D.Director,Global Learning and Development,Kendle,Cincinnati; Kendle is a global clinical research organization and a provider of Phase II to Phase IV clinical development services worldwide.For more information, visit kendle.com. BEV HUDSON.VP and General Manager, Research Services Group,Medpoint Communications Inc., Evanston, Ill.; Medpoint provides specialized communication and education services to the biopharmaceutical industry. For more information, visit medpt.com. ALICE JACKSON.CEO and Founder,Lifetree Clinical Research,Salt Lake City; Lifetree Clinical Research is a research organization offering multitherapeutic clinical trials management, drug development.and site service expertise in Phase I to Phase III clinical trials. For more information, visit lifetreeresearch.com. MIKE LADDIN.President,LeaderPoint, Mission, Kan.; LeaderPoint offers open enrollment,association, and private company sessions that are modular in design and proven to improve client business outcomes.For more information, visit leaderpoint.biz. JEANMARIE MARKHAM.CEO and President, Clinlogix LLC, North Wales,Pa.; Clinlogix is a solutionsoriented global clinical research organization. For more information, visit clinlogix.com. JULIE ZINN. Executive Director, Project Management and Business Skills Program, ESI International Inc., Arlington,Va.; ESI International provides project management,contract management, business analysis, sourcing management, and business skills training. For more information, visit esiintl.com. There has been very little education offered on an undergraduate or graduate level in pharmaceutical research. We end up training people on the job and that takes a lot of time, money,and effort. ALICE JACKSONWITHWAYNECROFT,Executive Director of Clinical Operations, at Lifetree Clinical Research DR.TERRI COOPER Deloitte From a training perspective, there has to be more skill development around contract negotiations, working in collaboration with external parties, and managing and reporting the deliveries from external parties. 0408 Layout FINAL MW 3/21/08 11:44 AM Page 56