Thursday, April 29, 2010

Clinical Development

No, not of baybee. This is a work-related rant. Start with Exhibit A:
One of my projects is writing a study protocol for an upcoming clinical trial, and I sometimes believe I am the only member of the clinical development team with a shred of common sense. Every week we meet, and every week we fail to get past item 2 of the 3-page agenda. People get side-tracked. They go off on tangents. I sit there on mute, waiting for any sign of my name being mentioned or a topic I remotely care about to be featured, and play Scrabble on my iPhone while I eat my lunch. It's a fabulous life, people. (It at least kicks ass to work from home.) The meetings always run over. Action items get deferred to the next meeting. Wonder why it takes so long for new drugs to get approved and make it to the market? Because we are stuck in a clinical development meeting arguing ad nauseum about whether or not we should select more study sites in Brazil than Germany (hint: who gives a fuck?!).

And there are the all-mighty pharmaceutical corporate processes. We are required to follow oodles of SOPs and process mandates so complex it takes a degree in library science just to locate them, let alone follow them. But follow them we must. Part of my job is to enforce these processes, since I prepare the regulatory documentation of the clinical research we plan, that gets sent to study investigational sites and eventually to the FDA or EU regulators. Saying that it's like herding cats is too cliche and too much of an understatement; it's more like getting a room full of cracked-out, rabid monkeys into a tiny cage (without getting pegged with poo, or your face ripped off by a pissed-off chimp). My team members like to waste precious meeting time taking turns bitching about how stupid the processes are, and finding sneaky ways to deviate and just do it their way. Listen, assholes, you are not the decision-makers, you are the decision-followers. When you rise up and become the Executive Director/Overlord/Emperor, you can use whatever process you fancy. But for now, you are but a minion, a tiny cog in a huge pill-manufacturing and money-making machine. [In my best sorority initiation voice: "Fry like bacon, little piggies!"]

I had to run today's meeting to lay out the various risks we are taking by moving forward toward internal approvals without key study design decisions made, for the sake of getting something done sooner rather than right. I had to introduce the concept (lo!) of risk mitigation to limit errors, omissions, failure to get approval (FAIL!), and blowing the project timeline out of the water. Yeah, it was a blast. I had to play bad cop for a solid hour. But, can I say, it was sort of fun? I am actually in my element when I am kicking ass and taking names. It made me feel kind of energized today. Hell, I might do some laundry. Living the dream here, people.

It sucks that, with a PhD and years of experience, I outrank -- and dare I say, outsmart -- half of my team; but, I am a contractor, so that knocks me down about three rungs on the ladder. [sigh] I miss being feared/respected by my students when I was an academic scientist. It was a real perk. I used to keep this picture on my lab bench to remind me what a Philosophy degree might have wrought:
It's funny because it's true.

1 comment:

bunny said...

That was awesome. I particularly liked the face ripping chimp shout out! But most awesome to me is that fact that I have one of those demotivators up in my lab, the one that says GET TO WORK. YOU'RE NOT BEING PAID TO BELIEVE IN THE POWER OF YOUR DREAMS.

Yeeeeah, smack those idiots around! Your normal behavior sounds a lot like me during department meetings. I figure the best contribution I can make is to reduce the total quantity of blathering. At a recent meeting some stupid-ass issue was debated for an HOUR before someone noted that we didn't even have a quorum to take a vote. Don't you wish you'd decided to stay in academia?