Senior Clinical Scientist

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

We are seeking an experienced Clinical Scientist / Senior Clinical Scientist Consultant (30 hours per/week) to support clinical development programs, with a strong emphasis on clinical trial protocol design, development, and execution.

Key Responsibilities

• Lead or contribute to the design, development, authoring, and amendment of clinical trial protocols across Phase I–III clinical studies.
• Collaborate with Medical Directors and Clinical Development leadership to develop scientifically sound study designs, objectives, endpoints, and eligibility criteria.
• Author and review clinical development documents, including protocols, protocol amendments, Investigator Brochures, Clinical Study Reports (CSRs), and informed consent documents.
• Provide scientific input into clinical trial strategy, study feasibility, and overall clinical development planning.
• Support ongoing clinical data review, including safety, efficacy, and emerging clinical findings.
• Partner with Biostatistics and Clinical Operations to ensure study designs align with scientific objectives and operational feasibility.
• Contribute to clinical study plans, data review activities, and interpretation of study results.
• Participate in cross-functional study team meetings and provide scientific guidance throughout clinical trial execution.
• Support regulatory submissions and interactions with regulatory authorities as needed.
• Identify potential scientific and clinical risks and recommend appropriate mitigation strategies.

Required Qualifications

• Bachelor's degree in Life Sciences, Biology, Pharmacology, or a related scientific discipline. Advanced degree (MS, PharmD, PhD) preferred.
• Experience as a Clinical Scientist, Clinical Development Scientist, Clinical Trial Scientist, or in a similar clinical development role within pharmaceutical or biotechnology companies.
• Demonstrated hands-on experience in clinical trial protocol design, development, and authoring.
• Experience supporting Rare Diseases
• Strong understanding of clinical study design, endpoints, inclusion/exclusion criteria, and clinical development processes.
• Experience supporting Phase I, II, or III clinical trials.
• Experience reviewing and interpreting clinical safety and efficacy data.
• Knowledge of ICH-GCP guidelines and applicable regulatory requirements.
• Excellent scientific writing, analytical, organizational, and communication skills.
• Ability to collaborate effectively with Medical Directors and cross-functional clinical development teams.

Preferred Qualifications

• Experience independently drafting or serving as a primary contributor to clinical trial protocols.
• Experience supporting global clinical development programs.
• Experience developing clinical study endpoints and contributing to statistical analysis planning.
• Familiarity with FDA and EMA regulatory requirements.
• Experience working in a fast-paced biotechnology environment