Program Manager Alignment And Integration: Best Practices When Working With A CDMO

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

This is the second 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 this Q&A, we continue 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.

How can companies better integrate program managers into early-stage scientific and business decision-making?

Stephen: In many organizations, program managers are brought in once a project is already defined. I believe this is a missed opportunity. Companies can benefit immensely by involving program management in early-stage scientific and business decision-making, especially in a fast-moving field like virology. Here’s how and why to integrate program managers earlier:

• Bringing Operational Foresight to Scientific Brainstorming: As early as lead candidate selection or preclinical planning, having a program manager in the room adds a perspective on feasibility and downstream implications. Researchers might be excited about a novel antiviral mechanism, but a program manager will ask the pragmatic questions: Do we have a scalable synthesis for this molecule? What if the required biosafety level is high – do we have a manufacturer with that containment? By raising these points early, we can steer scientific decisions toward options that are brilliant and executable. For example, in one early virology program, our team was debating two delivery platforms. It prompted us to consider manufacturing complexity: one platform would require ultra-cold storage at sites (a logistic nightmare), whereas the other had easier distribution. This input helped the team choose the platform that we could realistically develop and deliver. Early program manager engagement thus ensures that scientific choices are informed by operational reality, potentially saving the company from pursuing a path that falters later due to CMC or supply issues.
• Shaping a Coherent Development Strategy from Day One: Program managers think in terms of the whole product life cycle. By integrating PMs in initial business strategy discussions, you get a road map mentality at inception. We help outline the end-to-end plan from research to clinical trials to commercialization and identify what needs to happen now to enable later stages. For instance, if a virology startup is discussing which indication to pursue first, I might contribute analysis on the regulatory pathways or timeline to proof of concept for each option. If one route could get a Phase 1 result in 12 months versus another in 18 months, that’s vital for the business case. Additionally, I’ll highlight cross-functional needs: “If we aim for an accelerated approval, we should engage regulatory consultants now,” or “Our formulation for this antiviral might require early stability studies; let’s not wait until Phase 2 to think about that.” By having a program manager in these early talks, companies can bake in a realistic development plan alongside the scientific ambition. It’s about marrying the science with an executable strategy up front, rather than retrofitting one later.
• Early Risk Identification and Mitigation: In the nascent stages of a project, scientists and executives might not yet see certain risks, but an experienced program manager is actively looking for them. We conduct what I call a “premortem” in early development: envision what could cause the program to fail and address it proactively. For example, for a project, I flagged that a key ingredient was sourced from a single supplier in one country. This was during the project kickoff, when such supply chain details are easy to overlook. By raising it early, we found secondary suppliers and even explored making the ingredient in-house if needed. Likewise, early-stage programs often don’t have detailed risk management, which can lead to costly blind spots. Integrating a program manager means implementing risk management from the get-go, so we can establish risk registers, contingency plans, and “Go/No-Go” criteria for critical experiments. This way, as the project advances, many land mines have already been defused or at least recognized. Companies can avoid those sudden revelations (“We never thought about scale-up till now and it’s a problem!”) that derail timelines.
• Linking Early Decisions to Long-Term Business Goals: Program managers often serve as a bridge between the science team and the business leadership, even in early phases. By being present, we ensure that portfolio-level thinking is applied to project decisions. If the business goal is to be first-to-market, I’ll push in early meetings for decisions that favor speed (with acceptable risk). Alternatively, if the goal is a best-in-class efficacy for a chronic infection, I might suggest more thorough early studies even if they take a bit longer. The program manager can articulate how today’s scientific choice affects the overall program timeline, cost, and probability of success — key inputs for executives. This avoids scenarios where scientists choose a path that, unbeknownst to them, doesn’t align with the company’s top objectives. Early integration makes the program manager almost a co-pilot in strategy, aligning the scientific trajectory with the commercial destination from the start.
• Streamlining Transition from Research to Development: Usually, there’s a handoff point where a project moves from discovery (research) into formal development (with IND enabling studies, etc.). If a program manager has been involved early, this transition is much smoother. We will have already assembled cross-functional input on the plan, and we can start operationalizing even while research is ongoing. For example, if research shows a promising antiviral lead, I might quietly begin lining up a formulation development CMO or prepping internal analytics teams in advance. This can shave months off the schedule. Companies that silo the early research and only bring in program management at Phase 1 miss out on these efficiencies. By embedding program managers at project inception, the inevitable baton pass from science to development is more of a continuum. The groundwork (contracts, protocols, team roles) is often already laid by the time we formally “kick off” development.

In summary, involving program management in early-stage scientific and business decisions grounds big ideas in reality and sets the project up for success. It’s akin to having an architect involved from the concept phase of a building. Yes, you need the visionary (scientist) to design the cure, but you also need the planner (program manager) to ensure the foundation will support the vision. Especially in virology, where speed and adaptability are critical (as we saw in the pandemic), early program manager integration can mean the difference between a brilliant idea reaching patients or stumbling on the road because no one thought about the roadblocks ahead of time.

How do program managers help bridge the gap between scientific teams, commercial functions, and executive leadership — both within pharma companies and with CMOs?

Stephen: Program managers are often described as the “glue” in pharma organizations. This is especially true when coordinating between the highly scientific teams, the commercial and business side, and external partners like CMOs. In my role, I constantly translate and broker understanding between these groups, effectively bridging the gap so that everyone works toward the same vision:

• Translating Science to Business (and vice versa): One of my key functions is to ensure that breakthroughs in the lab are communicated in terms that business and leadership teams care about. Scientists might report, “We achieved a 10-fold increase in viral titer in the bioreactor,” but an executive or a CMO might need to hear, “This means we can produce 10x more doses by next quarter.” I take the deep technical details and frame them in the context of impact, timeline, and cost for the commercial folks. Conversely, I translate business directives into actionable terms for technical teams. If leadership says, “We need to file the IND by year-end to beat a competitor,” I break that down for the scientists and the CMO: what data must be ready by when, what that means for daily lab work or production runs. By being bilingual — speaking science and business — a program manager ensures that each group understands not just what is happening, but why it matters in the grand scheme. This prevents the classic disconnect where, say, the CMO team doesn’t grasp the urgency of a timeline, or the internal R&D team doesn’t understand a market-driven change in target product profile. Everyone stays in the loop in a language they get.
• Synchronizing Internal and External Priorities: The pharma/biotech company’s internal teams (R&D, clinical, marketing) have their priorities, and the CMO has its own business and operational priorities. These can diverge – for instance, our commercial team might be pushing for maximum yield to lower cost of goods, while the CMO might be more concerned with hitting a delivery date. Program management bridges this by aligning incentives and priorities between organizations. In practice, I negotiate and establish joint milestones and success criteria with the CMO at the start. We might agree that timeline is king for early clinical supply, whereas cost efficiency becomes more important at scale – making sure both our team and the CMO’s team understand the focus at each stage. I also facilitate what I call the “joint vision” meeting: bringing our scientists, our commercial lead, and the CMO’s project lead together to discuss the end goal (e.g., “Launch by next year with X doses ready.”). By creating a shared vision, I help each side see the project from the other’s perspective. Throughout the project, I then monitor decisions to ensure they serve that shared goal. If the CMO proposes a process change that might slow things down but improve yield, I’ll loop in our commercial people and scientists to evaluate the trade-off collectively rather than in isolation. This cross-functional, cross-company dialogue is orchestrated by the program manager, making sure internal strategy and CMO execution stay tightly coupled.
• Providing a Single Point of Contact and Truth: When bridging between scientific and leadership realms, consistency of information is critical. I act as the single point of contact so that the contract manufacturer’s updates flow to our internal leadership through me, and our leadership’s directives flow back likewise. This avoids the confusion of multiple voices. For example, instead of a researcher and a procurement manager separately emailing the CMO (possibly with conflicting requests), communication is funneled through the PM. We then deliver consolidated reports to all stakeholders. I maintain an integrated dashboard that shows project status such as scientific progress, manufacturing progress, regulatory status, etc., and share it with both our executives and the CMO’s team. Everyone is looking at the same data and the same KPIs. This single source of truth builds trust: the CMO doesn’t feel like we’re hiding the ball, and our executives feel they have direct line of sight, albeit mediated through program management. In meetings, I’ll present a high-level summary for leadership that is informed by gritty details from the scientific team. Because I’ve bridged those details to a clear message, leadership stays confident and the technical teams feel heard (their concerns were elevated accurately). Studies have shown that many outsourced project failures are not due to the science failing but due to breakdowns in communication and alignment essentially, gaps between these groups. By plugging those gaps, program managers keep the project from derailing for nontechnical reasons.
• Integrating Commercial Strategy with Development Execution: In virology especially, commercial considerations (like market entry timing or pricing/reimbursement strategy for a cure) can be as pivotal as the science. I bridge commercial and development teams by ensuring that commercial strategies are informed by the on-the-ground reality and vice versa. For example, if our commercial colleagues plan a big launch next year, I make sure they know the manufacturing lead times and regulatory steps, tempering any unrealistic expectations. At the same time, I push the development teams to consider commercial needs: perhaps formulating the drug for low-cost manufacturing if it’s intended for global markets or scaling up production in advance if a major marketing campaign is planned. I often facilitate cross-functional workshops where scientists, supply chain, marketing, and the CMO sit together to map out from production to patient. This holistic view is championed by program management, because we’re the ones looking across silos.
• Bridging at the Executive Level: Finally, bridging gaps isn’t just about day-to-day teams. It’s also between the companies’ leaderships. Often, the pharma/biotech executives and the CMO’s executives might only interact at high-level contract negotiations or if there’s a major issue. I support those relationships by keeping both informed and avoiding surprises. Before our executives meet the CMO’s executives in quarterly business reviews, I provide briefings, so each knows the concerns and achievements of the other side. Think of it like diplomatic prep work. By translating needs and ensuring transparency at the leadership level, program management helps maintain a productive, trust-based partnership rather than an adversarial one. In essence, we prevent the “us vs. them” mentality by continuously highlighting the common mission, delivering a therapy to patients. And if tensions do rise (perhaps a delay has occurred), I gather the facts from the scientific side, assess the mitigation plan, and present a clear case to both leadership teams on how we move forward. This level-headed mediation rooted in facts often defuses blame games and keeps everyone focused on solutions.

In summary, program managers bridge the gap by serving as translators, coordinators, and mediators between the scientific folks, the commercial/business side, and the external manufacturing partners. We ensure that all these moving parts remain connected to the project’s objectives. In practical terms, we speak all the dialects — technical, financial, regulatory — and convene all the players so that the brilliant science translates into a viable, delivered product supported by the whole organization and its partners. Without this bridge, even strong teams can drift into misalignment, but with it, the pharma company and its CMO act in harmony as one extended team.

As we continue the conversation in an upcoming Q&A, we will discuss the skills that program managers need for the future of biotech outsourcing.

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.