1. Fractional CMO leadership at critical inflection points

I take CMO-level ownership when the complexity, risk or external visibility of your programme requires experienced leadership — but the timing or structure does not justify a full-time hire.

Scope typically includes:

• Defining the clinical development and lifecycle value strategy
• Ownership of study portfolio, protocols and key decision documents
• Leading regulatory interactions and governance forums
• Supporting investor discussions, partnering processes and board communication
• Leadership and mentoring of internal clinical and medical teams

For US biotech companies entering Europe:

• EU clinical development and regulatory strategy
• Building the European medical and clinical operating model
• Translating global programmes into EU execution

2. From data package to an investable clinical programme

I translate existing data and assumptions into a development path that supports confident decisions, credible guidance and a realistic route to value.

Typical deliverables:

• Review of data package and development assumptions
• Definition of indication, endpoints, patient population and comparators
• High-level study concept aligned with regulatory and payer expectations
• Scenario analysis of timelines, capital requirements and key risks
• Materials for internal decision-making and external communication

3. Building Medical Affairs as a strategic value driver

I support companies that are establishing, scaling or refocusing Medical Affairs and need a structure that is aligned with corporate strategy and able to support both launch and long-term lifecycle value.

Typical scope:

• Clarifying the role of Medical Affairs in the organisation’s value model
• Developing a practical Medical Affairs plan aligned with corporate priorities
• Structuring medical–commercial collaboration and governance
• Defining evidence generation, KOL engagement, publication and MSL activities
• Coaching and mentoring medical and scientific staff

4. Senior medical review for high-stakes content and peak workload

Companies engage me when the scientific, regulatory or reputational importance of their materials requires experienced, independent medical juCompanies engage me when the scientific, regulatory or reputational importance of their materials requires experienced, independent medical judgement — or when internal capacity is temporarily insufficient.

I provide:

• Collaboration with internal reviewers, agencies and compliance teams
• Independent medical and scientific review of promotional and non-promotional materials
• Alignment with relevant codes of practice and compliance frameworks
• Structured review processes that reduce rework and ambiguity