Oncology Trial Protocol Lead

Life Science Recruitment; Connacht; On-site; EUR 90,000 - 130,000; Full time

Job summary

Life Science Recruitment's client, a medical device startup, is seeking a Clinical Trial Protocol Specialist to lead the design and authorship of investigational protocols for oncology trials. The role sits at the intersection of clinical science, regulatory strategy, and study operations, with a permanent position in Ireland.

The ideal candidate holds an MD/PhD/PharmD or equivalent, with 5+ years in protocol design for oncology, and a proven track record of authorship.

Qualifications

• 5+ years of experience in clinical trial protocol design and authorship in oncology.
• Proven ability to independently author oncology trial protocols.
• Deep knowledge of oncology endpoints and CTCAE grading.

Responsibilities

• Lead Design & Authorship: oversee Phase I-III oncology trials and draft protocols.
• Endpoint & Population: select endpoints and populations with scientific justification.
• Documentation Development: draft ICFs and patient questionnaires.
• Cross-Functional Collaboration: work with biostatistics on SAPs and with clinical advisors.
• Regulatory Compliance: align with ICH/FDA guidelines and support submissions.
• Research & Literature: conduct targeted reviews to support study design.

Skills

Protocol design

Oncology expertise

Regulatory knowledge

Scientific writing

Cross-functional collaboration

Education

MD/PhD/PharmD or equivalent

Job description

Life Science Recruitment's client, a medical device startup, is seeking a Clinical Trial Protocol Specialist to lead the design and authorship of investigational protocols for oncology trials. The role sits at the intersection of clinical science, regulatory strategy, and study operations, with a permanent position in Ireland.

The ideal candidate holds an MD/PhD/PharmD or equivalent, with 5+ years in protocol design for oncology, and a proven track record of authorship.