Senior Clinical Scientist: Protocol Design & Trial Strategy

Connect Life Sciences; North Carolina; On-site; USD 83,000 - 165,000; Part time

Job summary

Connect Life Sciences is seeking an experienced Clinical Scientist / Senior Clinical Scientist Consultant to support clinical development programs on a 30-hour-per-week schedule. The role emphasizes clinical trial protocol design, development, and execution, spanning Phase I–III studies, with close input from Medical Directors and Development leadership.

You will author and review key documents, contribute to study plans, oversee safety and efficacy data interpretation, and support regulatory

Qualifications

• Bachelor's degree in Life Sciences or related field; MS/PhD preferred.
• Hands-on experience in clinical trial protocol design and authoring.
• Experience supporting Rare Diseases.
• Strong understanding of study design, endpoints, inclusion/exclusion criteria, and regulatory processes.

Responsibilities

• Lead design, development, authoring, and amendment of clinical trial protocols across Phase I–III.
• Collaborate with Medical Directors to develop scientifically sound study designs and objectives.
• Author and review protocols, amendments, Investigator Brochures, CSRs, and informed consent documents.
• Provide scientific input into trial strategy, feasibility, and development planning.
• Support ongoing data review of safety and efficacy findings.
• Partner with Biostatistics and Clinical Operations to align designs with objectives and feasibility.
• Contribute to clinical study plans, data review, and interpretation of results.
• Participate in cross-functional study teams and provide scientific guidance during execution.
• Support regulatory submissions and interactions with authorities as needed.
• Identify risks and mitigation strategies.

Skills

Clinical trial protocol design

Regulatory understanding

Scientific writing

Cross-functional collaboration

ICH-GCP knowledge

Pharmacology knowledge

Clinical development

Biostatistics collaboration

Education

Bachelor's degree in Life Sciences

MS/PhD preferred

Job description

Connect Life Sciences is seeking an experienced Clinical Scientist / Senior Clinical Scientist Consultant to support clinical development programs on a 30-hour-per-week schedule. The role emphasizes clinical trial protocol design, development, and execution, spanning Phase I–III studies, with close input from Medical Directors and Development leadership.

You will author and review key documents, contribute to study plans, oversee safety and efficacy data interpretation, and support regulatory