Today’s post is written by Mark Joing, Chief Development Operations Officer at Marea Therapeutics. Here, he provides valuable tips for being an effective VP of clinical operations in biotech.
When I started my career in clinical operations, there were no VPs of clinical operations, at least in small biotech companies.
The head of clinical operations role was typically filled by a Director or perhaps Senior Director. However, the complexity of clinical trials has increased and the importance of getting trials conducted on time, within budget, and with high quality data has become paramount to effective drug development. Commensurately, the role of the head of clinical operations has become more challenging and more vital to company success. It is now common to see VP or even SVP of clinical operations jobs at all kinds of different biotech companies.
What does it take to become and be a senior leader in clinical operations? I have been in this role at multiple biotech companies, so while I do not claim to have cornered the market on advice for VPs of clinical operations, I will endeavor to share a few pearls of wisdom I have learned over the years.
This is not a treatise on being a good VP in any department or on being an effective leader. There are plenty of books and blogs on that topic. Instead, this article will provide insight into the specific skills and experiences that one needs to have success as a head of clinical operations within a small biotech environment.
In my experience, here are 5 tips for being an effective VP of clinical operations in biotech:
Build a deep and diverse network across clinical trial support functions and CROs
Biotech companies must rely on experienced staff and consultants who can hit the ground running with limited direction and hand holding.
VPs of clinical operations need to have a well-developed rolodex of people across a range of expertise and levels to be able to quickly add or change resources as the needs of the organization change over time. This includes traditional clin ops resources such as Clinical Trial Managers, Clinical Research Associates, and Clinical Trial Assistants, but often includes adjacent functions such as data management, drug safety, clinical trial materials management, and biostats.
The VP of clin ops also needs to have a deep knowledge of the CRO landscape from the full-service providers to the niche service providers (e.g. IRT, central lab, imaging, eDiary, etc.) to be able to quickly identify, evaluate, and assess options to support new or changing clinical trials. This often extends to a network beyond the US, as trials in Europe, Asia, and beyond are becoming the norm.
Strategic resourcing – balance insourced and outsourced resources
One of the first key decisions a VP of clinical operations must make is how much trial operational support can and should be done with internal staff and consultants and how much to outsource to CROs and other service providers.
Staffing trials with largely in-house resources requires a larger infrastructure of quality systems (e.g. SOPs), IT systems, and G&A support.
Every trial is unique – a small Phase 1 study in the US may be easily managed with a contract monitor and internal CTM, but a global Phase 3 study will likely require one or more CROs and specialized service providers.
A related decision is what proportion of internal resources is employed full-time vs. resources that are contracted as contractors or consultants. Trial support needs often ebb and flow, and I have found that a 50/50 mix of employees and contractors seems to be a good starting point for most situations.
Hone the ability to work across various executive levels, management structures, and leadership styles (CMO, CEO, CDO)
Biotechs often have different reporting structures for the VP of clinical operations.
Most often, I have seen this position report to either the CMO or CEO, but this person can also report to a CDO or COO.
The most important executive partner to the VP of clinical operations, regardless of reporting structure, is the CMO (or head MD if the company has no CMO). Does the CMO want to dig into the protocol writing, or is she looking to clinical operations to drive that with her input/review? Who makes the decision on which CRO to use for a study? Who is ultimately responsible for enrollment and trial timelines? There can be a natural tension between the CMO and VP of clinical operations, the former often having an advanced degree from a more prestigious institution, and the latter more likely to have worked their way up from the world of trial monitoring and management. Developing a highly effective relationship with the CMO should be top of the list for any VP of clinical operations.
Accrue strong skills in negotiation and budget management
Typically, 50% or more of a biotech’s budget runs through clinical trial and clinical operations. It is imperative that the VP of clin ops gets the most out of internal and external resources. The majority of this cost will be external and so be spent on CROs and other trial vendors.
Here a few specific tips on negotiating with CROs based on my experience:
- Do not select a CRO until you have negotiated key language in the MSA and the budget (once a CRO is selected, nearly all leverage to negotiate better terms and lower costs is lost)
- Use milestone payment structures when possible that align the company’s needs and CRO deliverables
- Refuse to accept up-front fees and cancellation fees
- After aligning on the scope of services and associated fees, always ask for a final discount on the total – most CROs will offer a 3-7% discount
In addition to external negotiation skills, the VP of clinical operations needs to be able to effectively manage the internal company budget and work closely with Finance to accurately record expenses and conduct budget vs/ actual analysis to understand where money is being spent and what is driving R&D expenditures. Most biotech companies use an accrual accounting method that records an expense when it has been earned or when the work has been done, rather than when an invoice is issued or received. This can add complexity to budget tracking, especially when using a milestone-based payment schedule.
Know how and when to leverage technology and innovation
Small biotech companies do not have the resources (money or staff) to implement and manage large and expensive software systems.
As a VP of clinical operations, I have nearly always decided to outsource software services to other companies who have gone through the expense and effort to implement, validate, and maintain these systems.
This includes drug safety databases, trial master files, and clinical trial management systems. One challenge with this approach is that this leads to disparate information and data that can be difficult and unwieldly to manage.
I am intrigued by recent innovation in this space to bring together trial information in one place. This includes efforts by large companies like Veeva, but also by more targeted and affordable solution providers such as Seascape Clinical (ClinOps Pro). These solutions may offer hope to small biotech VPs of clinical operations looking to more effectively manage clinical trials without breaking the bank.
