The Opportunity

An emerging, EU-based clinical-stage biotechnology company is preparing to advance its lead programme into the next stage of clinical development and is looking to appoint an experienced fractional Chief Medical Officer (CMO) to provide senior clinical and regulatory leadership.

The company has made strong progress towards its next financing milestone and is now beginning to build out the senior team required to support clinical development. The CMO will have the opportunity to become involved ahead of the financing completing, helping shape and execute the clinical strategy as the organisation moves towards a major development milestone.

Key Responsibilities

• Provide senior clinical leadership across the company's development programme

• Lead and refine the clinical development strategy for the lead asset as it progresses towards and through Phase 1b

• Coordinate closely with the clinical site, MHRA and external partners to prepare for clinical trial execution

• Provide strategic input into clinical trial design, execution and interpretation.

• Develop and oversee the clinical and regulatory strategy across European and US markets

• Support interactions with the MHRA, EMA and FDA

• Work collaboratively with regulatory, CMC and clinical operations colleagues to ensure development activities are fully aligned

• Provide senior oversight of external CROs, investigators, KOLs and other development partners

• Help shape the company's clinical organisation as it transitions towards a broader internal team

• Act as a senior clinical representative with external scientific, regulatory and commercial stakeholders

• Support the leadership team with clinical development strategy, programme prioritisation and key development decisions

Ideal Background

• Previous experience as a CMO, VP Clinical Development

• Proven leadership across both clinical development and regulatory strategy

• Experience taking assets through early clinical development, ideally Phase 1/Phase 2

• Background in rare disease, neuromuscular/muscle disease, neurodegeneration, mitochondrial disease or metabolic disease would be highly relevant

• Strong experience engaging with European and US regulatory authorities, particularly MHRA, EMA and FDA

• Experience working with academic clinical centres, CROs and other external development partners

• Comfortable operating within a lean, entrepreneurial biotech environment where senior leaders are expected to be hands-on

• Strong stakeholder management and communication skills

• A genuinely collaborative leadership style, with the ability to work alongside scientific founders, advisors and external experts rather than operating in a highly directive or hierarchical manner

Location

EU-based, with flexibility around working arrangements. Some travel may be required for key meetings, clinical site interactions and company activities.