The Strategic CMO

Objective: The Strategic CMO drives clinical and product development strategy supporting commercialization and impacting corporate valuation through key internal and external stakeholder and investor interactions. Clinical Development designs and maintains currency of all studies; works cross‐functionally to incorporate and balance regulatory requirements, payer data needs, and operational constraints in study designs. Clinical Operations operationalizes study designs for data generation to support registrational submissions. Medical Affairs focuses on data analysis, distillation, and dissemination so all stakeholders get the most current and accurate information on safety, efficacy, method of action, and differentiation of the company’s products. Challenge/problem: An experienced medical professional becomes CMO at a pre‐IPO gene therapy company – an exciting opportunity with challenges. How does the CMO remain strategic and prevent relegation – addressing urgent operational issues instead of building out a well thought‐through medical office? The CMO leveraged external partners focused on Medical Affairs, Pharmacovigilance and Clinical Development to help build the function and execute the strategy. Solution: Start Lean. Build a scalable framework. Expand with triggers. Outcome: Hire effectively to focus on value generating pieces. Leverage contractors and consultants for short‐term SME needs. Develop growth plans, models, and strategic frameworks. Identify potential new hires in advance to prepare for growth. Driven by corporate, regulatory, and competitive factors, expand the medical organization accordingly. Switch contractors and consultants to FTE’s once the role is proven valuable and needed. Benefits: One of the most successful newly launched companies, on its way towards becoming a leading gene therapy company

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