By Louis Garguilo, Chief Editor, Outsourced Pharma
Carol Sherako is a highly trained project manager. She humbly suggests other PMs in the biopharma industry should be, too. If biopharma is going to stick with the model of transitioning scientists from within its ranks to the status of PM, it ought to get serious about training them.
And what about at the CROs and CMOs? Are the individuals there better trained? Let’s begin our investigation there.
Practiced At The Partner
We learned in our first article that Sherako, Director Program Management at Sanofi-Genzyme, is a licensed project-management professional (Project Management Institute), has a business-management degree (Simmons School of Management), and a career spanning both sides of the biopharma outsourcing relationship.
She described how management at Sanofi-Genzyme determined their most productive project managers were those with the specific training, and the specialized skill set, for that vocation. Interestingly, it turned out those top-performing managers had gained a good deal of their training at service providers they’d worked for in the past.
“I was at a CRO that took the time and pain to beef up its project management system,” explains Sherako. “One way it did this was to hire outside, professional consultants to train the PMs. We also formed a team to bring the state of project management from what we considered to be immature, all the way through to mastery. It was a great experience that led me to further my study and enthusiasm for the field.”
A single anecdote doesn’t prove that CROs and CMOs are leaders in project-management training. But it certainly raises questions. How should both sides train their PMs? How should the PMs at sponsors and service suppliers coordinate? The point isn’t to determine if one side or the other is more advanced, but if both – separately and combined – are effectively advancing projects.
My PM Works Better With Yours
“Having worked for a CRO,” says Sherako, “I can tell you one of the biggest mistakes that sponsors make is not sharing the overall, cross-functional plan – their actual strategy for the project. Some say you can only share so much; I say if they really are your partner, you need to share more.”
When preparing to outsource the manufacture of clinical trial material, says Sherako, “I’m not selecting ‘discrete’ pieces of information.” She says it’s important the CMO understands “our goals and objectives from the start, and how the work they do fits into our overall plan. That gets them fully onboard and feeling like a partner.” She adds: “They’re as important as any internal team member. I think sometimes less experienced managers in the industry don’t really understand this.”
The process then works in reverse, with Genzyme learning the details about the project planning at the CMO. “We rely on them for their pieces of the puzzle – internal timelines, assessed production risks, quality controls,” Sherako says. “In fact, I take their Gantt chart and put it directly into ours, and we continue to track together to a critical path.
The CMO’s expertise is so critical to our project that if it doesn’t have a top-notch project manager, I’m tempted to panic. Experience tells me the project is not going to run as well as it could have.”
Sherako does separate the unalterable from the alterable in project planning. Sponsors have set timelines and other requirements driven by a variety of factors. A project plan from a CMO that calls for altering these is not going to be acceptable.
“But if that’s the case,” says Sherako, “it’s precisely where the sponsor has to provide the CMO as much information as possible. Without the larger picture, the CMO is often hamstrung in trying to deliver on all those non-negotiable requirements.”
Who’s Leading, Who’s Managing?
The preferred project model now employed at biotechs and pharma includes a dedicated project leader, focusing on the core team and day-to-day performance of the project, and a project manager, bringing experience in operational excellence, team functionality, and overall execution on deliverables. The first role interacts with his or her counterpart at a CRO/CMO; the latter fills the role of “alliance management” with key partners.
“I think the model works well,” says Sherako. “It allows for a trained individual to bring the full skill set of a professional project manger – detailed timeline planning, procurement expertise, risk management assessment – to the assistance of the frontline project leader. This skilled manager guides the project leader regarding the larger strategies, and facilitates cross-functional and external conversations.”
There are some points of concern in the model, though. With a project leader and manager on the same team, conflict can arise because of overlap in responsibilities ... and the sharing of credit if things work at well. The solution appears to be mostly one of open communication, and having the flexibility to negotiate – for the good of the project, and the individuals.
“If I’m on a project with a senior level scientist, with excellent leadership skills and willingness to manage the more operational components of the project, I might look to take a less active role,” explains Sherako. Conversely, she says, when working with a more junior scientist, with emerging leadership and management skills, she’d negotiate a more interactive role – almost of mentoring –to ensure the project has everything it needs to succeed. “The point is to understand people’s skill set, desires for professional growth, and then explicitly identify who does what.”
“I believe in this cross-functional team environment,” she adds emphatically. “And the project manager needs an advanced skillset to pull this off. People have thought that a project manager can be most any scientist taken from a project and moved into that level of position. I’ve seen too many times when that person ends up failing. There’s a need for more specific training and real experience.”
Training At Sanofi
Sanofi is one sponsor devoted to a more systematic training of its project managers. According to Sherako, the company starts with a pool of technically proficient scientists, who have self-identified with a desire – and the drive – to branch out into management. These individuals are typically younger employees (between 25 and 35). To move the best of these candidates forward, Sanofi has established a program of “preceptorship.” Like an apprenticeship, candidates are given the opportunity to shadow and learn from a trained program manager.
“This provides a cross-functional experience, and opens eyes to that need for a whole new skill set,” explains Sherako. “This is not to say that most of these individuals eventually end up being part of program management,” she continues. “This first exposure to allow for more self-analysis also weeds out position changes that would not have worked out.”
Along with the hands-on training, there’s also a large volume of training materials specific to project managers (see part one). “We encourage self-selected training, and require the reporting on goals and progress with that education,” she says.
Sherako looks to a better future. “It’ll be exciting to have these great resources who understand what we do for a living, how we operate, and most importantly, now be able to effectively manage it all,” concludes Sherako.
In other words, more professional PMs like her finally arriving in the biopharma industry.