Senior Clinical Scientist

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 .

The ideal candidate will have a solid scientific background, hands-on experience developing clinical study protocols, and the ability to collaborate with Medical Directors, Clinical Operations, Biostatistics, Regulatory Affairs, and other cross-functional teams.

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