Welcome to Partnology’s Biotech Leader Spotlight Series, where we highlight the remarkable accomplishments and visionary leadership of biotech industry pioneers. This series is about showcasing the groundbreaking strides made by exceptional leaders who have transformed scientific possibilities into tangible realities. Through insightful interviews, we invite you to join us in following the inspiring journeys of these executives who continue to shape the landscape of the biotech industry. This week we are recognizing:
Suzanne Vyvoda is a seasoned clinical development and operations leader, specializing in optimizing execution strategies across biotech and pharma. Over the past year, she has worked with seed-stage companies as a fractional Chief Development Officer and Chief Operating Officer, guiding them in building scalable operational frameworks and crafting investor-ready clinical development plans. With a reputation for transforming complex clinical and operational challenges into strategic solutions, she helps companies drive efficiency, accelerate growth, and achieve sustainable success.
Suzanne’s career spans all critical facets of clinical trials— including deep experience working at clinical sites, CRO management, and roles at large and small biotech and pharma companies. At Telavant, she was the first clinical operations hire, building a high-performing team from the ground up in just ten months. By fostering a collaborative culture and strong partnerships with CROs and clinical trial sites, she helped accelerate Telavant’s clinical programs, ultimately making the company an attractive acquisition candidate for Roche in under a year.
Prior to Telavant, Suzanne served as Vice President of Development Operations and Head of Clinical Operations at Applied Molecular Transport, where she successfully built and scaled the clinical operations team. Earlier in her career, she held leadership roles at AbbVie, Gilead Sciences, and BioMarin, managing clinical development programs across oncology, rare disease, infectious disease, and general medicine from Phase I-IV. With experience leading global trials across nearly 50 countries, she has developed a deep understanding of integrating clinical operations across diverse regulatory and operational landscapes.
Whether guiding startups through early-stage clinical planning or executing large-scale global trials, Suzanne thrives at the intersection of clinical development strategy and execution. She holds a B.S. in Sociology and Economics from the University of Utah.
Walk me through your career – highlighting pivotal moments that shaped your journey and what inspired you to pursue a career in drug development and clinical operations.
I specialize in clinical and development operations, partnering with early-stage biotech companies as a fractional Chief Operating Officer and Chief Development Officer. My role centers on helping founders build and execute investor-ready clinical strategies—whether securing seed funding or advancing late-stage assets. From budgeting and vendor oversight to trial execution and outsourcing, I bring the strategic and operational expertise needed to navigate clinical development efficiently.
After Telavant’s acquisition by Roche in 2023, I saw an opportunity to support emerging biotech companies in a rapidly shifting industry—one facing funding constraints, increased M&A activity, and frequent trial discontinuations. By providing fractional leadership, I help companies stay agile, ensuring their clinical programs are both strategically sound and operationally feasible.
With a career spanning over 20 years, I’ve built and led clinical operations teams at biotech startups and major pharma companies alike. I started at the site level, managing oncology trials at a major cancer hospital, where I saw firsthand the disconnect between protocol design and real-world patient needs. That early experience shaped my approach to clinical development—one that prioritizes efficiency, execution, and patient-centered innovation.
You’ve managed clinical operations across 40+ countries with significant budgets. What are the key factors to successfully navigating the complexities of global clinical trials?
Successfully managing global clinical trials requires a strategic approach that aligns with a company’s size, resources, and operational capabilities. While geography plays a role, the biggest differentiator is whether the trial is being conducted by a large pharma company or an emerging biotech. Large companies have the budgets and infrastructure to support expansive trials, while startups, often reliant on VC funding, must be more resourceful—making strategic trial design, efficient execution, and risk management essential. Understanding regulatory requirements early and building flexibility into trial design can help mitigate delays and unexpected challenges.
A well-defined outsourcing strategy is critical for trial success, regardless of the size of the trial sponsor. CROs, trial sites, and specialty vendors are not just service providers; they are key partners, and cultivating strong relationships with these stakeholders from the outset ensures alignment throughout the trial. Engaging a CRO as an intermediary between the site and sponsor has become standard practice, but success relies on proactive oversight, strong governance, and ensuring the CRO’s priorities align with the sponsor’s objectives. Establishing trust and clearly defining roles, expectations, and performance metrics helps ensure accountability across all partners. Aligning trial execution with the regulatory pathway that best supports approval further streamlines the development process, minimizing costly delays and maximizing the trial’s potential for success.
Geographic considerations also factor into trial execution, particularly when selecting sites and patient populations. Each clinical program requires a tailored approach—whether it’s a first-in-human study, a trial in a unique population or a large global Phase 3 program. Identifying the right sites with access to eligible patients is a fundamental step in trial success. Additionally, geopolitical factors, regulatory landscapes, and standard-of-care differences across countries must be considered to ensure smooth trial execution.
You’ve worked closely with CMOs and executive leaders on clinical development strategies. How do you ensure alignment between operational execution and strategic vision?
I’ve had the privilege of working with brilliant executives, scientists, and doctors who excel in shaping clinical development strategies from a medical and scientific perspective. However, translating these strategies into execution comes with its own set of challenges.
Operational success requires strong cross-functional alignment across clinical operations, program management, CMC, quality, preclinical, and other teams—all working toward a shared goal. In large global programs, ensuring adequate investigational product supply across multiple countries is critical. At the same time, accurately defining the target patient population and selecting the right endpoints are key to generating a robust data set for regulatory success.
Aligning executive expectations is just as critical as execution. Clinical trials are costly, time-intensive, and inherently unpredictable. Even with meticulous planning and site selection, underperformance at certain sites is a frequent challenge. Proactively guiding leadership teams through budget realities and timeline constraints helps set achievable expectations. My approach is to under-promise and over-deliver—ensuring transparency, managing risk, and positioning clinical programs for long-term success.
What trends or innovations in clinical operations do you think will have the biggest impact on the biotech and pharma industries in the coming years?
Several key trends are poised to shape clinical operations in the coming years, with AI leading the conversation. While its full impact is still unfolding, AI is already being explored to refine target identification, optimize early-stage research, and improve preclinical and IND-enabling studies—all of which have the potential to drive greater efficiency on the scientific front.
What I find particularly exciting is AI’s potential to transform clinical trial site identification and patient recruitment—two of the most persistent challenges contributing to high costs and long timelines. Despite significant efforts, the industry has historically struggled to systematically search across geographies and effectively engage eligible participants. AI could help us better match sites with the right patients, reducing delays and improving trial outcomes.
Despite advances in drug development, many processes remain outdated from a technology standpoint. However, in an industry shaped by rigorous regulatory requirements, any new advancements must align with compliance standards to drive real impact. I’m particularly interested in how AI and other innovations can streamline clinical operations, improving efficiency while upholding the highest regulatory standards.
What advice would you give to someone aspiring to lead global clinical operations in biotech or pharma?
There’s no single path to leading global clinical operations—professionals enter the field from diverse backgrounds, including clinical sites, CROs, nursing, pharmacy, and beyond. This diversity highlights one of the most important aspects of the industry: it’s heavily relationship-driven. Networking and building strong connections play a critical role in career transitions and opportunities.
One of the most valuable steps is identifying your transferable skills. Understanding how your expertise—whether from academia, clinical practice, or operations—applies to drug development is crucial. Effectively positioning and communicating those skills can open doors, especially when transitioning between sectors. It’s also essential to grasp how clinical trials function across biotech, pharma, CROs, and clinical sites, as each operates with unique priorities and challenges.
I often think of this transition as “putting on a different hat.” Consider how the actions taken at a site or CRO directly impact the sponsor and the overall success of a trial. If you’re transitioning from a site, CRO, or academia into biotech or pharma, it’s crucial to learn to speak the language of sponsors. Framing your experience in a way that aligns with the challenges they’re trying to solve will set you apart and help you thrive in this space.
