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Senior Clinical Scientist

Jobtailor

Provide scientific and clinical leadership for global clinical development activities in neurodegenerative disease, initially Parkinson’s disease and progressive supranuclear palsy Assemble, evaluate, interpret, and present scientific and medical data Lead or provide content for clinical documents Monitor the competitive landscape and critically review relevant literature Provide strategic input to clinical development programs and studies Design global Phase 1–3 studies with the clinical research physician Guide outcome-measure selection and interpretation, including MDS-UPDRS and PSP Rating Scale Contribute to data-collection tools, statistical analysis plans, case report forms, data-review plans, rater-training plans, and endpoint-quality strategies Collaborate with cross-functional study teams on study start-up, CRO and vendor selection, laboratory and imaging onboarding, rater qualification, and committee activities Lead clinical study protocols and contribute to investigator brochures, clinical study reports, safety update reports, regulatory documents, presentations, and publications Provide senior clinical-science leadership from study start-up through closeout Lead medical monitoring and clinical data-review plans Analyze efficacy, safety, biomarker, imaging, pharmacokinetic, and pharmacodynamic data Support dose selection, study adaptation, program strategy, benefit-risk interpretation, and recommendations to leadership, committees, investigators, and regulators Build relationships with investigators, key opinion leaders, patient advocacy organizations, clinical research networks, and external partners Support advisory boards and investigator meetings Travel domestically and internationally, approximately 20% Requirements 10+ years of relevant pharmaceutical or biotechnology clinical-development experience Substantial experience with global interventional studies and demonstrated leadership of early-phase clinical development Equivalent combinations of education and experience will be considered Clinical-development experience in neurodegenerative disease or movement disorders required Strong knowledge of ICH-GCP, drug-development processes, study design, statistics, clinical operations, and global regulatory expectations in neurodegenerative disease Working knowledge of longitudinal efficacy endpoints, clinical rating scales, rater variability, disease progression, placebo effects, missing data, and operational challenges in neurodegeneration trials Excellent project leadership, communication, and organizational skills Ability to lead matrix teams, exercise independent judgment, and influence program-level and cross-functional decisions Ability to interpret complex clinical and biomarker data and communicate conclusions, limitations, and recommendations to technical and nontechnical audiences Strong team orientation and ability to work independently and reliably deliver high-quality objectives on time Ability to use a computer and communicate via phone, video, and electronic messaging Ability to maintain general availability during standard business hours Ability to work without current or future visa sponsorship Advanced scientific or clinical degree required Doctoral-level degree such as PhD preferred; MSc/MPH with extensive directly relevant experience may be considered Core Competencies Demonstrates extensive expertise in clinical development for neurodegenerative diseases, with a strong focus on study design, regulatory compliance, and data analysis. Proven ability to lead cross-functional teams and communicate complex scientific information effectively. Highest-signal resume keywords Clinical Development Leadership Neurodegenerative Disease Expertise ICH-GCP Knowledge Project Leadership Data Analysis and Interpretation Hard Skills Clinical Study Design Statistical Analysis Data Collection Tools Efficacy Endpoint Analysis Regulatory Document Preparation Clinical Protocol Development Biomarker Data Analysis Pharmacokinetic Analysis Phase 1-3 Study Management Clinical Operations Soft Skills Communication Skills Organizational Skills Team Orientation Independent Judgment Influencing Skills Certifications & Qualifications Advanced Scientific or Clinical Degree Doctoral-Level Degree (PhD Preferred) Industry Keywords Neurodegenerative Disease Movement Disorders Global Interventional Studies Clinical Research Regulatory Expectations Clinical Rating Scales Study Adaptation Patient Advocacy Organizations CRO Selection Clinical Development Processes #J-18808-Ljbffr Jobtailor

Vacancy posted 3 days ago
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