Core Services
Gisselbaek Consulting provides senior medical, clinical development and Medical Affairs consulting for biotech, medtech, specialty pharma and life science investors. The focus is on the moments where clinical decisions, capital allocation, regulatory credibility and enterprise value are tightly connected.
1. Fractional senior medical leadership at critical inflection points
I take senior-level ownership when the complexity, risk or external visibility of a programme requires experienced leadership, but the timing or structure does not justify a full-time hire.
- Clinical development and lifecycle value strategy.
- Ownership of study portfolio, protocols and key decision documents.
- Regulatory interaction preparation and governance leadership.
- Support for investor discussions, partnering processes and board communication.
- Leadership and mentoring of internal clinical and medical teams.
Relevant page: Interim Medical Director and fractional CMO support.
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.
- Review of data package, clinical assumptions and evidence gaps.
- Definition of indication, endpoints, patient population and comparators.
- High-level study concept aligned with regulatory, payer and investor expectations.
- Scenario analysis of timelines, capital requirements, feasibility and key risks.
- Materials for internal decision-making and external communication.
Relevant page: Clinical development strategy consulting.
3. Medical Affairs as a strategic value driver
I support companies that are establishing, scaling or refocusing Medical Affairs and need a structure aligned with corporate strategy, evidence generation, launch readiness and lifecycle value.
- Clarifying the role of Medical Affairs in the organisation’s value model.
- Developing practical Medical Affairs plans 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.
Relevant page: Medical Affairs consulting for pharma and biotech.
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 judgement, or when internal capacity is temporarily insufficient.
This includes promotional and non-promotional materials, investor-facing scientific narratives, clinical documents, medical education content and high-visibility materials where accuracy, balance and compliance matter.
- Independent medical and scientific review of promotional and non-promotional materials.
- Review of investor, board and partner-facing scientific communication.
- Alignment with relevant codes of practice, compliance expectations and internal review processes.
- Collaboration with internal reviewers, agencies, medical, regulatory and compliance teams.
- Structured review processes that reduce rework, ambiguity and approval delays.
5. Investor and board due diligence
I support investors, boards and executive teams that need an independent medical and clinical perspective before financing, acquisition, partnering, portfolio prioritisation or strategic reset decisions.
- Assessment of clinical evidence strength and development assumptions.
- Risk review across study design, feasibility, endpoints, regulatory path and medical adoption.
- Clinical and medical input to investment theses, board materials and partner discussions.
- Identification of value inflection points and evidence required to reach them.
Relevant page: Life science investor due diligence.
Contact Gisselbaek Consulting to discuss the clinical, medical or organisational decision in front of you.