The Future of Biotech Outsourcing: Essential Skills for Program Managers

A conversation with George Stephen, director of global program management, Gilead Sciences

This is the third of a planned three-part series with George Stephen discussing program management when working with a CDMO. In the first Q&A, Life Science Connect’s Michelle Raley caught up with him to discuss the pitfalls that program managers help sponsor companies avoid, how program managers accelerate timelines or reduce risk, and how program managers align diverse stakeholders. In the second Q&A, we continued the conversation by discussing best practices for integrating program managers into a sponsor company and how program managers help bridge the gaps between various stakeholders within the sponsor company and with CDMOs. In this final Q&A of the series, we discuss the skills necessary for the future of biotech outsourcing.

As biotech development cycles speed up, what skills will be most important for next-generation program managers?

Stephen: As biotech development cycles speed up (think of how quickly COVID treatments/vaccines were developed) and outsourcing becomes even more integral, the role of the program manager is evolving. The next generation of program managers who liaise with contract manufacturers will need an expanded skillset to thrive in this high-speed, high-stakes environment. Key skills and attributes that will be most important include:

• Agility and Adaptive Planning: Traditional project management in pharma could be somewhat waterfall and linear. Now, with accelerated timelines, program managers must be adept at Agile methodologies and flexible planning. This means being comfortable with rapid iteration, reprioritizing on the fly, and managing projects in sprints rather than multiyear phases. Shorter development cycles and potentially virtual or concurrent development models demand that a PM can adjust plans quickly without losing sight of the end goal. In practice, this could involve running daily or weekly stand-ups with cross-functional teams (which was unheard of in pharma a decade ago), and empowering teams to make quicker decisions. Essentially, next-gen PMs need to embrace change and uncertainty, guiding teams through pivots and course-corrections as new data emerges. Agility also extends to regulatory strategy. For example, this means being ready to apply rolling submissions or adaptive trial designs. An agile program manager will facilitate these innovations rather than be a bystander. Speed is the name of the game, and the PM must be the catalyst for speed with control.

• Digital Savvy and Data-Driven Decision Making: The future of program management is data-heavy. Projects generate enormous amounts of data (from lab results to manufacturing quality metrics to market analytics). A next-gen PM should be comfortable with data analytics tools, visualization software, and digital project management platforms. They should know how to set up dashboards that, say, automatically pull assay turnaround times or CMO batch status, and highlight if something is trending off schedule. Proficiency in project management software (and even emerging AI-driven tools that can predict project risks) will set apart the great program managers. Moreover, the ability to interpret and leverage data to do scenario modeling, Monte Carlo simulations for timeline risk, or inventory projections will be crucial. Embracing digital tools also means enabling better remote and asynchronous collaboration (critical as teams are often global now). In short, tech fluency from using advanced Excel models to specialized PM software will be a must, replacing a lot of yesterday’s manual Gantt chart updates. Companies will look for program managers who can harness data for smarter, faster decisions.

• Deep Understanding of CMC and Supply Chain (Technical Acumen): In the context of liaising with contract manufacturers, future program managers benefit from strong technical knowledge of the manufacturing process, quality requirements, and supply chain logistics. While a PM isn’t expected to be a scientist, having a solid grounding in the science and engineering of your therapeutic area is incredibly helpful. For instance, knowing the basics of cell culture production, viral vector handling, or potency assays means the PM can have informed discussions with the CMO and internal tech teams. As timelines compress, there’s less time to learn as you go, so PMs with prior technical expertise will shine. Additionally, understanding supply chains is key, including sourcing of raw materials, cold chain distribution, etc. Next-gen program managers should develop vendor management expertise and supply chain awareness. If a critical reagent is back ordered globally, the PM should know this quickly and work with procurement to find alternatives. If a CMO is struggling with throughput, a technically savvy PM can grasp whether it’s an equipment issue, a process issue, or personnel and help problem-solve or escalate appropriately. In essence, more T-shaped skills will be valued: breadth across project domains but also a depth in CMC/manufacturing science to truly partner with technical teams rather than just project manage at a surface level.

• Enhanced People and Collaboration Skills: Paradoxically, the faster and more high-tech we get, the more important human leadership becomes. Program managers already need good people skills, but in the future, this will be even more critical, as they orchestrate larger, more distributed teams (often without direct authority). Skills like communication, negotiation, and conflict resolution will be paramount. For example, with multiple partners (maybe two CMOs, a CRO, and an internal team all in the mix), the PM must keep everyone motivated and resolve tensions quickly. The ability to inspire a shared vision and keep teams engaged during crunch times will define the next-gen PM. As development cycles shorten, stress and burnout risks increase on teams, so the PM will need to monitor team health and morale and inject optimism and clarity when things get chaotic. People skills are the most critical part of any project, as one industry source highlights, and I fully agree. That includes managing upward (influencing leadership) and outward (stakeholder management with partners). We’ll also see the importance of cultural agility, as working with overseas manufacturers means understanding cultural nuances in communication and decision-making. The future PM who can build trust across diverse teams and serve as a collaborative leader, rather than just task manager, will excel.

• Advanced Risk Management and Scenario Planning: Faster timelines mean less margin for error, so anticipating and mitigating risks becomes even more vital. Future program managers need sharpened risk management skills such as the ability to foresee what could go wrong and have a plan ready. This includes technical risks, regulatory risks (changing guidelines), and supply risks (shortages, geopolitical issues). Next-gen PMs might employ more formal risk analysis tools and keep live risk registers that are revisited frequently, not shelved. They’ll also practice scenario planning: If the Phase 1 viral challenge fails, what are plan B and C? If the CMO’s facility goes down, do we have a backup? During COVID, we learned to plan for extreme scenarios; that mindset will stay. A program manager who can quickly reallocate resources or adjust timelines in response to a risk manifesting will be highly valued. In essence, resilience and adaptability, backed by concrete contingency plans, will be key skills.

• Continuous Learning and Domain Expertise: The pace of biotech means new technologies (think mRNA, gene therapies for viral diseases, AI in R&D) are emerging rapidly. Program managers of the future must be avid learners, staying updated on scientific and regulatory developments in their domain. For example, if a new regulatory pathway for a treatment is introduced, the PM should educate the team and integrate it into strategy. Or if a novel manufacturing tech can halve production time, the PM should know enough to advocate for evaluating it. This overlaps with technical acumen, but it’s broader. It’s about being a domain expert and trend watcher, not just a timeline tracker. A next-gen program manager is almost a mini-chief operating officer of the program, combining operational execution with strategic awareness of the field.

In conclusion, tomorrow’s program managers will wear even more hats: part project manager, part data analyst, part supply chain specialist, part diplomat, and always a leader. The fundamentals remain: organize, communicate, and drive execution, but the toolkit is expanding. Those who can integrate analytics, digital tools, business acumen, and exceptional people skills will be the ones to successfully steer the fast-paced development programs of the future. As development cycles in biotech speed up, the program manager is the person making sure that “faster” doesn’t turn into “chaotic”; instead, it becomes faster with discipline. By evolving our skills in the ways I’ve discussed above, we can continue to bridge science and execution in an era where every week saved might mean thousands of lives saved or a big competitive edge in the market. The next-gen program manager, especially in partnership with contract manufacturers, will truly be the linchpin of rapid and successful drug development.

About The Expert:

George Stephen is director of global program management at Gilead Sciences. He is an accomplished pharmaceutical executive with over 15 years of global experience leading cross-functional drug development programs, strategic planning initiatives, and portfolio management in the biotech and life sciences industries. He holds an MBA from the University of Chicago Booth School of Business and has been featured in Science Times for his leadership in COVID-19 treatment development.