Strategy without tactics is the slowest route to victory. Tactics without strategy is the noise before defeat.
– The Art of War, by Sun Tzu, c. 500BC
Over the past five years, I have led workstreams for five new product launches (with four different manufacturers). Every launch is crazy– it doesn’t matter whether it’s Big Pharma or Biotech Startup. But I sincerely believe how your team feels about the launch, and consequently, the quality of their work, hinges on three things:
- The Brand Lead (usually the Executive Director, Brand Marketing in Big Pharma; often the VP of Marketing in smaller companies): Teams hang in there, sometimes despite (multiple) Complete Response Letters (CRLs) from the FDA, if they have a great boss. Good leaders share a clear vision, support their team in meeting, if not exceeding, expectations, and demonstrate that they genuinely care about their people.

2. The Corporate Infrastructure: Does the team have the tools they need to do their jobs? Legal, Finance, IT… stuff can’t get done if there is no one to negotiate contracts, pay the bills, and make sure the (digital) lights are on. Ditto on human capacity. Sure, everyone can roll up their sleeves and jump in to help where they can, but there is absolutely a tipping point where staff burnout, resentment, and decline in output outweigh any benefit of “running lean.” The flip side is a large, exceptionally well-resourced organization with a matrixed org structure and multi-step approval processes (contracts negotiation, PO generation, MRL-approval) operating at a geologic era rate. Bureaucracy can bog down a team, too.

3) The Launch Project Manager: This poor soul is often left to mediate between strategists and tacticians but is appreciated by neither.
I know some will argue that the bronze should go to the Agency of Record or Commercial Training. I will stick my neck out and say that a solid project manager can make or break a launch. The build to a commercial drug launch will have the following players:
- Competing priorities
- Limited resources
- Drop-dead deadlines
- High regulatory scrutiny
- Multiple internal and external stakeholders
- Strong personalities
- A complex web of interdependencies
What could go wrong?

Often the Manufacturer will hire a contractor or outside consultant to project manage a commercial launch. Generally, the individual tasked with the responsibility is a recent B-school grad (or team of them) who can work into the wee hours converting whiteboard scribbles into .ppt. True, they may have access to their firm’s catalog of RAID templates and Gantt charts, but they probably don’t have enough industry experience to see problems before they happen. They can provide administrative support, but when I refer to a Project Manager, I’m thinking specifically of someone who 1) has both Pharma in-line and launch experience and 2) may not be an expert but is aware of IT, Finance, Reg, and Legal considerations. Some manufacturers do have an in-house (director-level) role, often called a “Strat Planner,” who is essentially the Brand Lead’s right hand. THAT’s whom I’m talking about.

If you’re launching a new therapy, does your team have someone in that role? I’m willing to wager that the answer is no. And that is a shame because prioritizing the planning and execution of the launch will elevate the contributions of everyone on the launch team.
My follow-up question: Why not?
To be clear: I am not a project manager.
People tend to do the things they’re good at, and I will tell you right now: I’m not a good project manager. I never sign up for those gigs. Folks who’ve worked with me may be surprised by the above (or not;-P). “Wait, I’ve been on launch teams with you; I’ve seen you lead workstreams and drill down on RAID logs and negotiate timelines.” Nope. That wasn’t me. Those deliverables were from a solid project manager. She put the jigsaw puzzle together. We reviewed it, and together we figured out if we had Starry Night or Dogs Playing Poker. I told her why I needed the missing pieces. She told me they were missing in the first place.

In my opinion, having a skilled project manager and formal project management process accomplishes three key things:
1) Leadership must articulate their goals (out loud), and their strategy is documented and communicated across the organization. I think we’ve all had the (frustrating) experience of working for the Brand Lead savant who has a brilliant vision, but it’s written only on the interior side of their forehead. The right project manager should be able to communicate that strategy and tie all team activities together. If the leadership needs to pivot, then the project manager can cascade new information to the team. You eliminate the telephone game and reduce the number of interpretations.
2) Decision-making is reduced to the lowest appropriate level, and decisions are memorialized. There is scope creep, and then there is “no one can do it right, so I’ll take it on, too” savior complex. Clear accountabilities, specific deliverables tied to dates, or particular milestones allow the team to acknowledge where the functional (or performance) weaknesses lie. And by trusting people to make decisions and actually do the job you hired them to do, you empower your team and support each individual’s personal agency. I have had the pleasure of working with super sharp, overachieving all-stars, and I gotta tell you: nothing can kill a team’s morale faster than micromanaging them.
3) Siloes are broken down. You reduce duplication of effort. You build camaraderie across functional areas.

In my experience, the most successful project managers possess a specific skill set and personality type:
- PMP Certified: I’m typically not impressed by academic pedigree or certificates, but I have found that the strongest project managers I’ve had the pleasure to work with were all PMP-certified. Whenever I’m working with a service provider for a significant initiative, I always try to negotiate with the vendor to include a PMP Certified team member in their staffing proposal.
- Ability to influence without authority: Nudge, don’t nag. Bad project managers make people resentful and feel like they’re going to tell Mom on them. Good project managers will see when you’re struggling and understand what’s gumming up the works.
- Excellent communication skills: They can tell a story in (groan) PowerPoint, their emails are crisp, and they do not mince words. More importantly, they are able to hold both project and organizational perspectives simultaneously.
- Finally: They have thick skin. Not leather-thick; like, leatherback turtle thick. Successful project managers understand that they will sometimes be the bearer of bad news, and they recognize that reactions are not to be taken personally. They are as much a coach as they are a cheerleader.
If you know (or are) a free-lance project manager with direct experience in Biotech/Pharma commercial launch planning, please drop me a line. I love connecting fantastic people with great work.
