Senior Oncology Trial Protocol Lead

Luminatemed; Galway; On-site; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Pension

Company laptop

Headphones

Camera

Job summary

Luminate Medical seeks a Clinical Trial Protocol Specialist to lead design and authorship of investigational protocols across our oncology portfolio. This hands-on, high-ownership role sits at the intersection of clinical science, regulatory strategy and study operations.

You will deliver feasibility, study synopses and protocol amendments while collaborating with biostatistics and regulatory teams to ensure robust, submission-ready documentation.

Qualifications

• MD/PhD/PharmD or equivalent in life sciences, medicine, or related field with oncology background.
• 5+ years of experience designing and authoring clinical trial protocols in oncology.
• Track record of independently authored oncology protocols.
• Proficiency with oncology endpoints and CTCAE grading.
• Strong knowledge of ICH guidelines and FDA regulatory expectations.
• Excellent written and verbal communication skills.

Responsibilities

• Lead protocol design and authorship for Phase I-III oncology trials, including feasibility, pilot and pivotal studies.
• Draft and revise study documentation such as informed consent forms and study questionnaires.
• Collaborate with biostatistics partners on endpoint selection and statistical analysis plans.
• Coordinate with clinical and regulatory teams to ensure study design and narratives are scientifically and regulatorily sound.
• Support regulatory submissions with protocol narratives and scientific rationales.
• Conduct targeted literature reviews to support design assumptions.

Skills

Creative

Open to feedback

Communicative

Self-driven

Organised

Education

MD/PhD/PharmD or equivalent

Job description

Luminate Medical seeks a Clinical Trial Protocol Specialist to lead design and authorship of investigational protocols across our oncology portfolio. This hands-on, high-ownership role sits at the intersection of clinical science, regulatory strategy and study operations.

You will deliver feasibility, study synopses and protocol amendments while collaborating with biostatistics and regulatory teams to ensure robust, submission-ready documentation.