Core Services

In brief

Which senior medical services does Gisselbaek Consulting provide?

The consultancy provides five primary services. They can be delivered as focused advisory projects, hands-on assignments or fractional and interim leadership, depending on the decision and level of ownership required.

  1. Fractional Senior Medical Leadership
  2. Clinical Development Strategy / Investable Clinical Programme
  3. Medical Affairs Strategy
  4. Senior Medical Review
  5. Investor & Board Due Diligence

Gisselbaek Consulting provides senior medical, clinical development and Medical Affairs support for biotech, medtech, specialty pharma and life-science investors across the Nordics, Europe and the UK. The work is most relevant at moments where clinical decisions, capital allocation, regulatory credibility and enterprise value are tightly connected.

The five services below are designed for organisations that need experienced medical judgement and practical ownership without necessarily making a permanent senior hire.

1. Fractional senior medical leadership at critical inflection points

I take senior-level medical 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.

This is relevant for biotech, medtech and specialty-pharma organisations across the Nordics, Europe and the UK that need CMO- or Medical-Director-level judgement combined with hands-on execution.

Relevant page: Interim Medical Director and fractional CMO support.

2. From data package to an investable clinical programme

I translate existing data, assumptions and scientific rationale into a clinical development path that supports confident decisions, credible guidance and a realistic route to regulatory, payer and enterprise 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.

This can apply at headquarters, in regional organisations or at affiliate level, particularly when a company is preparing for launch, geographic expansion or a more strategic Medical Affairs role.

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.

The aim is not simply to approve content, but to strengthen scientific credibility, clarity and the quality of the decision or external conversation it must support.

Relevant page: Senior medical review for high-stakes content.

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.

This support is designed for investors, boards and executive teams that need an independent clinical and medical perspective before financing, acquisition, partnering, portfolio prioritisation or a strategic reset.

Relevant page: Life science investor due diligence.

The senior medical expert you meet is the senior medical expert who does the work. Support can be fractional, interim or focused on a defined decision, project or value-inflection point.

Complementary support: medical and scientific team capability building

Capability building can be incorporated into a broader assignment when the objective is not only to resolve the immediate question, but also to strengthen the medical or scientific team’s ability to make future decisions. Focused mentoring or capability-building engagements can also be arranged where senior medical judgement, organisational development or leadership support is required.

Explore mentoring and capability building

Interview series

Explore the services through short interviews

This six-part interview series introduces Gisselbaek Consulting and explores the central questions behind each core service.

Start with the brief introduction, or go directly to the topic most relevant to your organisation.

Contact Gisselbaek Consulting to discuss the clinical, medical or organisational decision in front of you.