Senior Clinical Scientist

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 .

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

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

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

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