Biotech leaders are asked to do a lot; move fast, manage limited resources, and guide teams through very different stages of development. In this episode of The Emerging Biotech Leader, host Kim Kushner talks with Dr. Benit Maru, Senior Vice President at SSI Strategy, about what it really looks like to lead in that environment.

They cover:

• The contrasts between early and late development leadership, and why those transitions can feel like two different roles
• How scenario planning and structured conversations help teams prepare for uncertainty
• Why documents like the clinical development plan or target product profile should be seen as living tools, not paper exercises
• The similarities and differences in leading across modalities—devices, biologics, and advanced therapies like cell and gene
• The importance of team dynamics, culture, and knowing when to bring in outside expertise

This episode is full of practical takeaways for biotech leaders who want to keep their strategies sound, their teams aligned, and their programs moving forward under pressure.

In this episode of The Emerging Biotech Leader, Kim Kushner speaks with Dr. Michael Goldstein, ophthalmologist and multi-time Chief Medical Officer, about the realities of biotech leadership across modalities and development stages.

Dr. Goldstein reflects on lessons learned from leading clinical programs in small molecules, biologics, gene therapies, cell therapies, and drug-device combinations. The discussion highlights what remains consistent across modalities such as the need for regulatory clarity and cross-functional alignment, and what differs significantly, particularly in manufacturing complexity, immune responses, and development timelines.

Other key themes include:

• Why time is an underappreciated constraint in biotech
• The strategic role of the CMO in manufacturing oversight and decision-making
• How to balance regulatory and commercial thinking in early development
• Building teams that function as integrated units, not parallel functions
• Advice for early-career CMOs seeking to grow beyond clinical roles

This episode offers practical insight into how biotech leaders can operate more effectively across the full development arc, from IND to commercialization, without losing sight of the clinical and patient perspective.

What does it take to bring patient-focused values into the real decisions that shape drug development, especially when you're moving fast, working lean, and under pressure to deliver?

In this episode, host Kim Kushner speaks with Victoria Oswald, Vice President at SSI Strategy, about how biotech teams can start small but think deliberately when embedding patient input and cultural intent into early-stage development.

Together they explore:

• Why even basic decisions in Phase I, like assessment burden or endpoint design, should reflect patient relevance, not just regulatory safety
• How teams can integrate patient perspectives without large budgets or formal infrastructure
• The tension between doing what’s feasible now vs. setting up for long-term alignment
• The role of internal culture in shaping how development teams prioritize, communicate, and make trade-offs

Drawing on her work across gene therapy, rare disease, and oncology, Victoria highlights how early engagement, shared mindset, and cross-functional awareness can help even lean teams avoid rework and stay focused on what truly matters.

This episode offers insight for biotech leaders and clinical teams working to connect patient priorities with real-world development choices from the start.