Standing Up Medical Affairs Department for Clinical-Stage Gene Therapy Company

The Client

Quality Talent. Exceptional Results.

What's the secret sauce for this boutique consulting firm? Its people. This firm strongly believes that delivering exceptional and long-lasting results starts by developing its talent to be the best it can be — making the impossible possible for clients. 

The Situation

Moving the Medical Affairs Function Forward

Due to the accelerated pace of medical innovations — whether it be new drugs, devices, or gene therapies — the medical affairs function has risen in prominence over the years. Even more so today as demand for clinical and drug information and new regulations increase. 

So when this clinical-stage gene therapy company decided it was time to relook its medical affairs function, they hired a medical affairs leader to lead the charge.  

But before a team could be defined, it was important for the medical affairs leader to first understand the current state of the gene company’s medical affairs function. There was just one caveat: The gene company wanted this project to be completed within six weeks. 

It soon became clear to the medical affairs leader that additional help would be needed to develop a certified medical affairs unit that could successfully bridge the research and commercial side of the business. This led the company to engage the boutique consulting firm to help them reach their objectives. 

Seeing how quickly the client wanted to move and given that current resources were tied up to other client initiatives, the boutique consulting firm decided to look for outside help. The firm wanted to onboard an independent life sciences expert with 5-10 years of professional experience working within the medical affairs space.

The Solution

Retaining Medical Affairs Expertise

Having worked with Graphite to onboard independent experts in the past, the firm decided to once again use the on-demand talent acquisition model for this initiative. But with a slight change in approach. Instead of having to start a fresh search for the right expert, they were able to re-engage an independent expert with whom they had a successful experience in the past.

So the firm engaged with its AE to gauge the expert’s interest and availability. Using the platform's expert availability features, the AE was able to verify that the expert did indeed have some availability to take on a new project. This enabled the AE to schedule a meeting via the Graphite meeting room between the firm and the expert. 

After discussing the scope of work, pay rate, and hours worked per week, the expert and the firm agreed to work together on this new initiative. Within 48 hours, the expert was onboarded to the project, and the project kicked off without any delays. 


A Medical Affairs Unit Built for the Future

Before getting started, the expert worked with the medical affairs leader and the gene company's cross-functional regulatory team to conduct a strategy assessment and gap analysis. Getting this critical work done first would enable the gene therapy company to understand where its strengths and areas of improvement lie. 

With the findings documented, the expert collaborated with the regulatory team to define and track timelines for when the unit and key processes would be developed. The expert had to conduct various stakeholder interviews with several department heads to determine responsibilities, interdependencies, and manage timelines to get this information. 

Once the basis of the new medical affairs team was defined, the expert worked with the medical affairs leader to set up the department. The expert provided project management support where needed and participated in developing any deliverables or materials that would be shared with leadership and internal/external stakeholders. 

When the gene company creates a new drug today, it's well-positioned to share information with the general public as part of its go-to-market strategy. 

Satisfied with the expert's deliverables and results, the firm has continued to retain them for similar initiatives. When asked why, the firm cited the platform's ease of use in communicating and paying experts and the quality of the network as reasons for retaining Graphite as a trusted partner.