I work with hematology, oncology and immunology companies at the inflection points that define a launch: the 12 to 24 months before a US or EU filing, when the science is ready and the medical infrastructure is not.
The engagements below reflect what I have been asked to do repeatedly over two decades, across companies that range from single-asset Series B biotechs to global pharmaceutical organisations.
Medical Affairs Build
Most pre-commercial biotechs underestimate what it takes to build a credible medical function. Hiring a Medical Director six months before launch is not a strategy. It is a risk.
I design and build Medical Affairs organisations from the ground up – team structure, governance, role definitions, operating model, and the processes that allow a small team to punch above its weight. At Seattle Genetics I built an 18-person European MA organisation across 7 countries in 12 months, in time for the Tukysa launch in HER2-positive breast cancer.
This is relevant if: You have a Phase 2 or Phase 3 asset, a launch horizon within 24 months, and no medical infrastructure yet in place.
Launch Strategy
A regulatory approval opens a window. It does not guarantee a launch.
The decisions that determine whether a launch succeeds are made 18 to 36 months before the first prescription: endpoint selection, label strategy, KOL engagement, publication sequencing, evidence generation for HTA. I have led or contributed to EMA and FDA approvals across lymphoma, breast cancer, and AML, and I know which decisions can be recovered and which cannot.
This is relevant if: You are 12 to 24 months from a US or EU filing and need senior medical leadership on the strategic decisions, not just execution support.
Scientific Communications
Data does not speak for itself. The question is whether your scientific narrative is built early enough to shape how your data is interpreted, or late enough that others have already framed it for you.
I develop publication plans, medical writing strategies, and scientific review frameworks that align with your regulatory and commercial objectives. I have contributed to 18 peer-reviewed publications and supported scientific communications across multiple major oncology launches.
This is relevant if: You need a publication plan, a congress strategy, or a scientific narrative that holds up under KOL and payer scrutiny.
KOL Strategy and Field Medical
KOL relationships are not built at launch. They are built years before, when the science is still being shaped and the investigators still have room to contribute.
I bring over 65 established Tier-1 KOL relationships across Europe in haematology and oncology, and I design the MSL strategies and field medical models that translate those relationships into scientific credibility and real-world evidence. I also help companies define what their MSL team should be doing at each stage of development, and hire accordingly.
This is relevant if: You are planning your first MSL deployment, designing a KOL advisory board, or trying to establish scientific presence in Europe ahead of a launch.
Pipeline and Early Development
The endpoint you choose in Phase 2 is the label you defend in Phase 3. The scientific narrative you build in early development is the one your MA team will work from for the next decade.
I work with development teams to align medical affairs strategy with clinical development – endpoint rationale, patient population framing, competitive differentiation, and the evidence generation gaps that matter most to regulators and payers. At Takeda I led global cross-functional MA leadership across oncology early pipeline with a focus on immuno-oncology, colorectal cancer, and lung cancer.
This is relevant if: You have a Phase 1 or Phase 2 asset and want to build the medical strategy before the pivotal readout, not after.
How I Work
I work as a Fractional CMO – embedded, senior, and accountable, without the overhead of a full-time hire. Most engagements run between 3 and 12 months, with scope defined by milestone rather than calendar.
I work independently and within The NemetzGroup consulting team, which gives clients access to a broader commercial, regulatory, and strategic network where the engagement requires it.
If you are building toward a US or EU launch and want to talk through where you are and what you need, the best starting point is a direct conversation.