Clinical operations translates scientific research into the studies and data needed to bring new therapies to patients. In this episode of The Emerging Biotech Leader, host Ramin Farhood speaks with Sharon Arnold, a seasoned clinical operations executive with more than two decades of experience in both large pharma and emerging biotechs, about how operational leadership determines whether innovation reaches the clinic successfully.

Effective clinical operations extend well beyond trial execution. When the function helps shape the protocol early, by focusing on clarity, feasibility, and patient experience, teams stay aligned and data remain reliable. Building quality into each step reduces late-stage corrections and inspection risk.

For growing biotechs, the challenge is to scale without losing control. Success depends on choosing carefully what to build internally and what to outsource, while keeping direct oversight of data management, statistics, and the trial master file. These functions anchor the credibility of the program and protect the integrity of the evidence that supports it.

AI and data-driven tools are reshaping how feasibility and enrollment are planned. They can highlight new patterns in site performance and patient availability, but their value depends on interpretation. Data still needs to be tested against real-world conditions and reviewed by people who understand the therapeutic area, the protocol, and the practical limits of execution.

Patient inclusion should be built into operations from the start. Early collaboration with investigators and academic partners supports stronger site performance, while engagement with advocacy groups helps patients stay informed and invested in the study. Diversity and understanding are part of what makes a trial executable and its data meaningful.

Clinical operations sits at the intersection of science, strategy, and delivery. This conversation sheds light on what strong operational leadership really looks like: the decisions that prevent costly detours, the structures that sustain quality, and the mindset that turns a promising molecule into a viable medicine.

Catch the full conversation to hear how thoughtful operational leadership keeps programs on course and trials moving forward.

In this conversation, Kim Kushner and Adriana Valenciano, Head of Client Delivery at SSI Strategy, take a closer look at what truly drives progress in early-stage biotechs. Picking up on themes first raised by Dr. Ed Tucker, they explore how leadership partnership, the structure of a Target Product Profile, and the intentional use of AI all shape how young organizations grow.

In biotech’s earliest stages, the relationship between the CEO and Chief Medical Officer often determines whether a company builds momentum or stalls in misalignment. When these roles evolve together, sharing a view of how science, business, and culture intersect, the organization gains the clarity to move fast without losing direction.

That clarity is reinforced by a strong Target Product Profile (TPP). More than a regulatory document, the TPP functions as a living blueprint that connects clinical strategy to company purpose. Used well, it aligns teams across functions, sets measurable targets for efficacy and value, and keeps both the scientific and organizational focus anchored to a shared definition of success.

Innovation also depends on intentional design. With new AI tools transforming how work gets done, early biotechs face a pivotal question: how to introduce technology without losing the human judgment and governance that protect sound science. Building those checks and balances too late risks chaos; building them too early can slow down the momentum. The challenge is knowing when to formalize, what to automate, and how to keep scientific integrity at the core.

This discussion is about the discipline of leadership in complex systems, how culture, decision-making, and innovation reinforce each other when guided by a clear framework and an honest partnership at the top. Listen to explore how shared intent and disciplined structure translate vision into progress.

Being a Chief Medical Officer looks very different on the inside than it does from the outside. In this episode, Dr. Ed Tucker talks openly about what he’s learned after serving as CMO in companies big and small. He traces his path from large pharma training grounds to the unpredictable world of startups, and what that shift taught him about adaptability, trust, and resilience.

Along the way, Ed talks about:

• Carrying the pressure of being “the voice of the science” in front of investors and regulators, and why alignment with the CEO is non-negotiable.
• Building trust with KOLs and investigators so that confidence outside the company translates into motivation and problem-solving inside the team.
• Using the Target Product Profile as the anchor of the program—a reference point that keeps assumptions in check and the whole team aligned on what they’re building toward.
• Seeing safety as a strategic lever, not just an operational task, and how a stronger safety profile can become the reason a drug succeeds in a crowded market.
• Learning that resilience matters more than endurance, and why humility and curiosity are essential traits for any CMO.
• Relying on the CMO community and networks for perspective and support, especially when facing the inevitable setbacks in drug development.

This is not a formula or a checklist, but a set of lived lessons. What emerges is an honest look at the role from someone who’s still learning, even after a decade in the seat.

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.

In this episode, Kim speaks with Jill Milne, Ph.D., CEO of Astria Therapeutics, about what it really takes to build a biotech company around patient needs, not just in mission statements, but in everyday decisions. Drawing on her 25+ years in pharma and biotech, Jill shares how Astria is redefining what it means to be patient-first, why culture is more than a slogan, and how leaders can align boards and investors behind values that also deliver business results.

They talk about:

• Patient-Centricity as Strategy: Jill details how Astria embeds patient insight across every phase of development; from target product profile to clinical design to commercialization. This is not just about listening sessions or checkbox advocacy, it’s about consistently translating lived experiences into decisions that accelerate development, improve retention, and drive value.

• Culture being a Strategic Asset: With the motto “Patients first. People always,” Jill emphasizes how every function, from finance to CMC, is connected to patient impact. The culture extends beyond Astria’s walls to CROs and partners, creating a shared mindset that scales.

• Board & Business Alignment: Jill outlines a compelling case for why patient-centered and culture-led approaches aren't just feel-good strategies but force multipliers that enhance clinical development, commercial positioning, investor confidence, and regulatory credibility.

For biotech leaders building companies with long-term impact in mind, this episode offers a grounded look at how values like culture and patient focus can be turned into consistent, daily execution.