{"id":142,"date":"2014-02-05T20:57:51","date_gmt":"2014-02-06T01:57:51","guid":{"rendered":"http:\/\/waife.com\/home\/?p=142"},"modified":"2014-02-05T20:59:41","modified_gmt":"2014-02-06T01:59:41","slug":"my-fiefdom-right-or-wrong","status":"publish","type":"post","link":"http:\/\/waife.com\/home\/my-fiefdom-right-or-wrong\/","title":{"rendered":"My Fiefdom, Right or Wrong"},"content":{"rendered":"<p><strong>My Fiefdom, Right or Wrong<\/strong><br \/>\n<br \/>\nIf asked, I imagine that most any pharmaceutical executive would say that their company works very well across individual functions. They would say that no one can develop drugs without thorough cooperation throughout the discovery and development process. \u201cAfter all,\u201d they would say, \u201cwe have all these inter-departmental teams, don\u2019t we?\u201d<br \/>\n<br \/>\nYes indeed they do have those teams, but a team doesn\u2019t create respect, trust, efficiency, or productivity by itself. And standing in the way of cross-functional nimbleness are the kings and queens of the pharmaceutical fiefdoms and their loyal subjects. Too often, it\u2019s \u201cmy good\u201d over the \u201cgreater good\u201d; it\u2019s \u201cmy fiefdom, right or wrong\u201d.<br \/>\n<br \/>\nWhile all sponsors eventually get out good therapeutic products, the industry remains plagued by chronic inefficiencies. Clinical development has many sources of inefficiency, and one of them is the failure of the diverse professions involved in clinical research to work together productively on a consistent basis. Certainly there are particular projects, or particular leaders, or particular moments in time when the stars and planets align, where people do get along well. But these are moments, and do not represent standard practice.<br \/>\n<br \/>\n<strong>This Land is My Land<\/strong><br \/>\nMost interdepartmental activities (project teams, process change projects, technology implementations, acquisition teams) show little tolerance for pressure, unexpected events, disagreements or changes in management direction (in other words, life). We see teams, carefully constructed with the best of intentions, all too frequently dissolve into recrimination, passive-aggressive withholding, and hallway politicking when the going gets tough.<br \/>\n<br \/>\nAnd this isn\u2019t just about teams. It is about the very organizational structure of clinical development itself. Obviously clinical development needs physicians, clinical operations staff, CRAs, data managers, software programmers, statisticians and medical writers. What we don\u2019t need is for each group to place its allegiance first to their department, second to their profession, and last to the company trying to improve human health.<br \/>\n<br \/>\nThen you have one of the common methods of process adaptation in vogue today: the creation of \u201croles\u201d, as distinct from jobs \u00a1\u00a9 essentially a superset of responsibilities assigned to higher performing individuals without any increase in compensation or diminution of their original responsibilities. By proliferating roles without letting go of profession-based structures, you have double the bureaucracy and double the pressure without really making an improvement.<br \/>\n<br \/>\n<strong>Organizing for Failure<\/strong><br \/>\nOrganization charts are the language of a company. A company speaks through these documents: it tells us what is important to them and what is not important, what it values, and how well it understands itself. Too often we see companies organizing for failure.<br \/>\nThe first clue comes when you ask to see the organization chart and are told that human resources won\u2019t let you see it. We know of several companies where managers can\u2019t even see the organization chart of their own department! Then you know the company language has lost its tongue.<br \/>\n<br \/>\nWhat are common ways that companies organize for failure? Organizing to protect egos is organizing for failure. Organizing to \u201cprop up\u201d someone\u2019s headcount to justify their title is organizing for failure. If you cannot achieve at least \u201clogical intimacy\u201d among functions, much less true interconnectedness, then you are organizing for failure. If you organize around visionaries instead of managers, you are organizing for failure. But one of the most dangerous trends in pharmaceutical companies today is organizational fragmentation.<br \/>\n<br \/>\n<strong>This Village is My Village<\/strong><br \/>\nWarring fiefdoms is one thing. War within the fiefdom is much worse. There is a growing tendency at some pharma companies to respond to process problems by further fragmenting their organization chart into smaller and smaller pieces. The thinking is that professional specialization will somehow inspire higher performance (ironic, at a time when CRA specialization by therapeutic area is nearly universally rejected in favor of regionally-based generalists). Examples of fragmentation in clinical departments are moves like organizing support functions into their own department, breaking up the monitoring function into several specialized jobs, or breaking up clinical data management into micro-constituencies (programmers, database managers, data managers, data analysts). The worst symptom of fragmentation is when the pieces are sprinkled hither and yon in odd ways organizationally.<br \/>\n<br \/>\nWhy is fragmentation so damaging? When you create a micro-profession you compound the essential problem we are describing: the creation of tribes who define themselves by who they are not. The more tribal we are, the more distrustful and disrespectful they are, by human nature. Worse yet, each new fragment (say, clinical site document specialists) has to create its own department. And what does that mean? It has to have its own meetings, its own representative on the interdepartmental team, its own career path and job ladder. The micro-profession becomes self-fulfilling and self-perpetuating. A tactic designed to innovate roles ends up instead creating yet another principality, with full regalia. In sum, instead of a source of efficiency, it is a cost-generating machine.<br \/>\n<br \/>\n<strong>This Fiefdom is Our Land<\/strong><br \/>\nThis is not meant as a polemic against organizational innovation. Rather, I encourage companies to examine their initiatives in terms of their output. Are objective measures of performance improving? Can managers and workers alike say there is less finger-pointing and more respect?<br \/>\n<br \/>\nOne method of organizational innovation that breaches borders is to lead with focus. Ask yourself, \u201cwhat is the most thing (or two) which our company needs the organization (clinical development as a whole) to accomplish in the next two years?\u201d Figure that out and organize around those objectives, not around disciplines or roles. If the job of clinical development is to get this drug (or three drugs) to submission, then that\u2019s what you need to focus on. If clinical development needs to develop this one drug for sure, and needs to change its processes to electronic trials, then those are the two things you should focus on. Nothing else. Organize around these projects and don\u2019t chicken out. Ongoing professional development can always be fed by the many ample means of professional education and communication which exist for every discipline. You don\u2019t need to re-create that in your company; organize around what you are trying to do, not who you are.<br \/>\n<br \/>\nIf people are organized around a sense of purpose, and only so, you are likely to see much greater success because people need to learn to trust and respect each other in order for the work to get done. Imagine if Major League Baseball was organized by position: all the second basemen in one department, the catchers in another, the third base coaches in another. And each day they were asked to come together as a \u201cteam\u201d and win a ballgame. That\u2019s what we try to do every day of the year.<br \/>\n<br \/>\nAretha Franklin was the \u201cQueen of Soul\u201d. The keys to her kingdom were R-E-S-P-E-C-T. If we all follow Aretha\u2019s way, avoiding mistrust and fragmentation, then maybe all of clinical development can be one productive land, and even a nice place to work, combining professional and corporate success.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>My Fiefdom, Right or Wrong If asked, I imagine that most any pharmaceutical executive would say that their company works very well across individual functions. They would say that no one can develop drugs without thorough cooperation throughout the discovery and development process. \u201cAfter all,\u201d they would say, \u201cwe have all these inter-departmental teams, don\u2019t we?\u201d Yes indeed they do have those teams, but a team doesn\u2019t create respect, trust, efficiency, or productivity by itself. And standing in the way of cross-functional nimbleness are the kings and queens of the pharmaceutical fiefdoms and their loyal subjects. Too often, it\u2019s \u201cmy good\u201d over the \u201cgreater good\u201d; it\u2019s \u201cmy fiefdom, right or wrong\u201d. While all sponsors eventually get out good therapeutic products, the industry remains plagued by chronic inefficiencies. Clinical development has many sources of inefficiency, and one of them is the failure of the diverse professions involved in clinical research to work together productively on a consistent basis. Certainly there are particular projects, or particular leaders, or particular moments in time when the stars and planets align, where people do get along well. But these are moments, and do not represent standard practice. This Land is My Land Most interdepartmental activities [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50],"tags":[],"class_list":["post-142","post","type-post","status-publish","format-standard","hentry","category-recent-columns"],"_links":{"self":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/142","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/comments?post=142"}],"version-history":[{"count":3,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/142\/revisions"}],"predecessor-version":[{"id":145,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/142\/revisions\/145"}],"wp:attachment":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/media?parent=142"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/categories?post=142"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/tags?post=142"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}