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Drive the science behind life‑changing rare disease studies with rigor, insight, and clinical excellence. Proclinical is seeking a Senior Clinical Scientist to support clinical development activities in the rare disease space. This role involves contributing to program strategy, study execution, and regulatory compliance while collaborating with cross-functional teams. The successful candidate will have a strong scientific background, familiarity with drug development processes, and experience in clinical research.
Job Responsibility:
Participate in program team meetings, scientific advisory boards, study steering committees, and data-safety monitoring meetings
Represent the clinical function in collaborative activities with other departments
Maintain a thorough understanding of therapeutic disease areas, drug candidates, and clinical practices, ensuring compliance with FDA, EMEA, ICH, and GCP guidelines
Propose, design, and execute clinical research studies for early- and late-stage assets, supported by scientific literature
Collaborate with medical writing teams to author and review clinical trial protocols, amendments, and other trial-related documents
Lead the preparation of materials for external stakeholder meetings, including investigator meetings, governance discussions, and regulatory authority presentations
Conduct clinical and medical data reviews, including safety monitoring, to ensure patient safety
Identify risks in program objectives and design mitigation strategies
Promote consistent clinical data review techniques across studies and programs
Requirements:
Degree in life sciences or healthcare
advanced degrees (PhD, MD, PharmD, MSc) preferred
Experience in pharmaceutical clinical drug development, with a focus on CNS, rare diseases, or cardio-metabolism preferred
Solid knowledge of clinical research regulatory requirements (e.g., GCP, ICH)
Strong analytical skills to interpret clinical trial data and synthesize conclusions
Ability to manage multiple priorities with effective planning and time management
Proficient in designing and executing clinical research studies and authoring related documents
Strong problem-solving, conflict resolution, and critical thinking skills
Excellent communication, technical writing, and presentation abilities