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Senior Clinical Scientist

$158k - $188k
Full-time

Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Scientist based in United States. This is a senior clinical development role supporting innovative regenerative therapies designed to address significant unmet needs in ophthalmology. You will serve as a scientific lead for one or more clinical programs, contributing across trial design, execution, data interpretation, and regulatory activities. The role offers broad exposure to the full clinical trial lifecycle, from protocol development and study startup through database lock, reporting, and submissions. You will collaborate closely with Clinical Operations, Medical Affairs, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Quality, and external partners. Your scientific insights will help shape clinical strategy, identify risks, interpret emerging data, and support informed development decisions. The position also provides opportunities to contribute to publications, scientific presentations, regulatory interactions, and relationships with investigators and key opinion leaders. This fully remote U. S. opportunity offers a salary range of $158,000–$188,000, with candidates in select states eligible and travel of up to 15% expected. Accountabilities: As a Senior Clinical Scientist, you will provide scientific leadership across assigned ophthalmology clinical programs and help ensure studies are designed, executed, analyzed, and communicated effectively. You will work across the clinical development organization and with external partners to translate scientific objectives into high-quality clinical programs. - Contribute to clinical strategy and the development of clinical development plans. - Translate scientific and medical objectives into operationally feasible clinical trial designs. - Identify clinical development risks and proactively develop appropriate mitigation strategies.

- Lead or support the development of study protocols, amendments, informed consent documents, case report forms, and other clinical study materials. - Support site feasibility assessments and investigator selection activities. - Provide scientific oversight throughout study startup, enrollment, study conduct, database lock, and closeout. - Partner with Clinical Operations to address protocol questions, eligibility determinations, deviations, and study conduct challenges. - Support medical monitoring activities and contribute to patient and clinical data cleaning. - Participate in investigator meetings, study team meetings, safety and data review meetings, advisory boards, and vendor meetings. - Ensure clinical studies are conducted in accordance with protocols, ICH-GCP, applicable regulations, and organizational procedures. - Partner with Biometrics and Data Management teams to develop data review plans and maintain high standards of data quality. - Review and interpret clinical, efficacy, safety, imaging, biomarker, and pharmacokinetic data as applicable. - Evaluate emerging study results and provide meaningful scientific and clinical insights to support program decisions. - Contribute to regulatory meeting preparation and interactions with global health authorities. - Support the preparation of regulatory briefing materials, responses to agency questions, and submission documents. - Contribute scientific content to INDs, CTAs, annual reports, clinical study reports, and marketing applications. - Lead or support the development of clinical study reports, abstracts, posters, manuscripts, and scientific presentations. - Support publication strategy and the dissemination of clinical data to scientific audiences. - Present study findings to senior leadership, investigators, advisory boards, and external scientific stakeholders.

Vacancy posted 11 days ago
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