The role of the Chief Medical Officer (CMO) is critically important, whether a member of the company’s management team or an outsourced provider. Companies understandably take great pains to identify and vet the right candidates – often prioritizing deep expertise in a specific disease or therapeutic indication. Perhaps surprisingly, this isn’t necessarily the right qualification to guide the search.
Fractional CMOs add significant value that derives from wide-ranging experience, as opposed to narrow but deep focus in one area. What, then, are the criteria that matter most in finding the best candidate for your company? These are the qualities to look for.
Strategic vs. Operational Orientation – Strategic orientation, encompassing a vision that aligns with the company’s growth trajectory, is key for earlier-stage companies who require such guidance well in advance of the clinic. A strategic CMO will ensure that programs are planned and guided with the end in mind. While operational expertise is also important, it’s more applicable once the development candidate has advanced to clinical trials.
Clinical Development vs. Medical Affairs Background – CMOs generally arrive at the position from a background in one or the other. While a blend of those skill sets is ideal, the right fit depends on the company’s stage of development. A clinical development background is well suited for earlier stages, whereas medical affairs experience becomes more important in later clinical stages.
Appreciation of the Regulatory Environment – Navigating the regulatory landscape demands nuanced expertise, especially in collaboration with entities like the FDA. A CMO with previous FDA experience understands the regulatory nuances and can translate them into actionable strategies that expedite trials and regulatory approvals. Their proficiency in engaging with regulatory bodies can help streamline the path toward successful outcomes.
Experience in Both Big Pharma and Smaller Biotech Companies – The need for both backgrounds is important so that the CMO appreciates the culture and expectations of big pharma (who may be the development partner) and the operational and financial constraints faced by small biotech companies (who lack the “safety net” of big pharma).
Communication Skills Across Multiple Stakeholders – A CMO’s role extends beyond clinical expertise; it entails effective communication with diverse stakeholders. From investors and key opinion leaders (KOLs) to the board of directors (BoD), investigators, and trial sites, adept communication fosters collaboration and trust, which is crucial for driving successful clinical trials and company growth.
Clinical Trial Design Capability – While a fundamental skill, the ability to design clinical trials isn’t the sole determinant of a capable CMO. It’s a prerequisite skill assumed at this level. What distinguishes a capable CMO is their capacity to utilize this skill within a broader strategic framework, to develop a thoughtful trial strategy.
The Right Person at the Right Time – While disease-specific expertise may seem desirable, a CMO’s value transcends singular domains. A competent CMO, irrespective of disease background, brings to the table a strategic vision, operational acumen, regulatory expertise, diverse industry experience, and exceptional communication skills, which collectively drive an organization’s growth and success.
The right CMO at the right time, equipped with a multifaceted skill set, proves instrumental in propelling early-stage companies toward their milestones, funding goals, and market success.