Interim Head of Clinical Operations

Walker Cole International is currently partnered with a Biotech searching for an Interim Head of Clinical Operations in Europe for an initial 6-month contract commencing in 2026 to support a Phase II Rare Disease clinical study.

Key Responsibilities:

• Provide strategic leadership and oversight for the delivery of a global Phase II rare disease clinical trial.
• Lead clinical operations strategy, ensuring efficient execution in line with timelines, budget, and quality standards.
• Oversee CROs, vendors, and specialty service providers, ensuring compliance and high-quality performance.
• Ensure adherence to ICH-GCP, EU Clinical Trial Regulation (EU CTR), orphan drug frameworks, and country-specific regulations.
• Develop and implement innovative patient recruitment and retention strategies tailored to rare disease populations.
• Manage relationships with key investigators, patient advocacy groups, and specialist centres.
• Establish and optimise clinical operations processes, governance structures, and SOPs.
• Identify and mitigate operational risks, ensuring inspection readiness and regulatory compliance.
• Collaborate cross-functionally with Regulatory Affairs, Medical Affairs, Biometrics, Pharmacovigilance, and Quality Assurance.
• Provide executive-level updates to senior leadership and investors on study progress, timelines, and key milestones.

Required Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline; an advanced degree is preferred.
• Extensive experience in clinical operations within a biotech, pharmaceutical, or CRO environment.
• Proven track record of leading Phase II clinical trials, preferably within rare diseases.
• Demonstrated leadership experience at Director or Head of Clinical Operations level.
• Strong knowledge of ICH-GCP, EU CTR, and global regulatory requirements.
• Experience managing global CROs, vendors, and complex clinical development programmes.
• Expertise in study feasibility, site selection, and operational strategy for small patient populations.
• Excellent leadership, stakeholder management, and communication skills.
• Proficiency in clinical systems such as CTMS, eTMF, and EDC platforms.

Preferred Qualifications:

• Prior experience in rare diseases and orphan drug development.
• Familiarity with EMA orphan drug designation and regulatory pathways.
• Experience working with patient registries, natural history studies, and adaptive trial designs.
• Background in therapeutic areas such as genetic disorders, metabolic diseases, or neurology.
• Proven experience in a small or mid-sized biotech environment.
• PMP, PRINCE2, or equivalent project management certification.
• Previous experience in an interim or consultancy capacity.

Contract Details:

• Start Date: April-May 2026
• Work Schedule: Full-time (flexible depending on project needs)
• Rate: €140–€150 per hour (dependent on experience level)
• Duration: 6 months (with likely extension)
• Location: Europe – Remote

Head of Clinical Operations | Interim | Rare Disease | Orphan Drug | Phase II | Clinical Operations | Clinical Development | Contract | Contractor | Biotech | Biopharma | EU CTR | Remote Europe