Clinical-Stage Gene Therapy Company Sets Up Medical Affairs Unit

The Client

A Patient-First Approach   

Developing gene therapy products that solve ocular and rare diseases is at the heart of this clinical-stage gene therapy company. They use science, technology, and expertise to devise the best solutions that will improve patients' lives. And the company does it all by understanding the environmental impacts of its research.

The Situation

Setting Up the Medical Affairs Department

The accelerated pace of medical innovations has increased the demand for clinical and drug information amid increased regulations. The distribution of information is important to educate patients about breakthrough innovations that improve their lives.

Because of these industry trends and shifts, the clinical-stage gene therapy company decided it was time to build out a proper medical affairs unit. Before forming a new department, this work was being conducted by multiple cross-functional teams but lacked the cohesion and strategy to drive impact. 

So they started the process of building out the new unit by hiring a medical affairs leader to run the new department. This person would then work with the existing regulatory team, acting as the bridge that connects the research and commercial side of the business. 

But to move forward with the project, given the expedited timeline, the medical affairs leader realized it would need additional support. That's because the existing core team was currently working on executing ongoing initiatives. So the medical affairs leader set out to find an independent life sciences consultant with 5-10 years of experience.

The Solution

Onboarding Medical Affairs Expert with Big Four Background  

Finding the right expertise in today's labor market is difficult, even more so in the life sciences space. After conducting market research on the best sources for onboarding independent life sciences consultants, the medical affairs leader came across Graphite.

Satisfied with the depth of life sciences experts on the platform, the onboarding process, and the ability to accurately and easily manage worker classification processes, the medical affairs leader decided to engage their dedicated Graphite account executive (AE). Together they discussed the scope of work, the required experience they were looking for, and the length of the engagement. 

Using that information, the AE delivered a shortlist of four life sciences candidates within 62 hours. Delighted with the quick turnaround, the medical affairs leader set up multiple interviews with each candidate in Graphite's in-app meeting rooms. 

After connecting with each expert, the medical affairs leader decided to move forward with a global life sciences consultant. The independent expert had over 18 years of experience leading cross-functional enterprise-wide transformations with a Big Four background.


An Integrated Medical Affairs Unit 

The expert started the initiative by first conducting a strategy assessment and gap analysis. This assessment would reveal the firm's current strengths and weaknesses — highlighting key areas for improvement. 

Once documented, the findings were presented to the cross-functional team leads. Doing so would ensure that the teams across the organization were in alignment with the current state of the medical affairs function and the next steps that would need to be taken to flesh out the future state. 

With the teams in agreement, the expert worked with the regulatory team to define timelines, milestones, and processes for developing the future state. The expert conducted several stakeholder interviews with various department heads to kick-start this part of the initiative. This provided the expert with the information needed to determine responsibilities and interdependencies. 

After several weeks of engaging with stakeholders, the expert and medical affairs leader moved to the project's execution phase. The expert was then tasked with providing project management support where needed. 

With the basis of the medical affairs department now defined and reorganized for maximum impact, the gene therapy company now has a system for disseminating clinical and drug information. It also has a better go-to-market framework to facilitate the launch of products. 

Throughout the engagement, the AE connected with both the expert and the company at key milestones during the project to ensure things were moving smoothly. Both the expert and the client enjoyed using Graphite’s platform to track hours, invoices, and process payments. 

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Clinical-Stage Gene Therapy Company Sets Up Medical Affairs Unit

Clinical-Stage Gene Therapy Company Onboards Independent Expert to Set Up Medical Affairs Unit

Skills Onboarded
About the Client
Project Duration
Independent Experts Hired
Project Booking Value


Key roles identified and onboarded

Eager to onboard a team that could achieve results within six months, the client and their dedicated Graphite account manager partnered to determinze the specifications for each of the four roles. They were:

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Gabriela Ziffermann

Digital Messaging Program Manager
  • Provide expertise in creating digital two-way communications compliant with federal government regulations (via text, email, and online portal)
  • Working with internal developers and product managers to implement the messaging rollout.
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