Dir. Clinical Scientist

Job Title: Dir. Clinical Scientist

Job Number: 90358

Location: , US

Job Description

Company seeking a clinical scientist with significant oncology expertise to contribute to various aspects of clinical development, with an emphasis on early-phase activities. The role requires a hybrid schedule, working on-site 2-3 days per week.

Responsibilities

* Lead the development and review of clinical documents, including protocols, ICFs, and synopses, ensuring alignment across teams. * Serve as a subject matter expert on drug products, protocols, and projects, supporting cross-functional stakeholders. * Contribute to pharmacovigilance activities such as safety monitoring, patient narratives, and aggregate reports. * Develop and implement data review strategies to ensure protocol consistency, data quality, and subject safety. * Provide guidance on clinical protocols, CRF design, and study execution plans. * Support site-facing activities, including CRA training, SIVs, and investigator meetings. * Monitor clinical data trends, lead data reviews, and collaborate with teams to address quality issues. * Ensure consistent study execution to facilitate regulatory submissions and data analysis. * Manage vendor coordination, timelines, and risk mitigation efforts with Program Management and Clinical Operations. * Stay updated on therapeutic developments through research, KOL interactions, and scientific meetings. * Facilitate Safety Review Committees and advisory board meetings, including preparation and coordination. * Contribute to clinical development strategy, regulatory submissions, and study-related documents, ensuring compliance with ICH/GCP and SOPs. * Support regulatory interactions with briefing documents, presentations, and responses.

Required Skills

* Advanced degree in Life Sciences (Master’s with 12+ years; PhD or MD preferred). * 8+ years in clinical development, including 2+ years in Sponsor roles. * Experience with GCP/ICH, study protocols, ICFs, and clinical reports. * Skilled in protocol comprehension, data review, and trend analysis. * Strong project management and problem-solving abilities. * Excellent communication skills for clinical, business, and scientific audiences. * Highly organized, collaborative, and adaptable in fast-paced environments. * Detail-oriented with a commitment to quality and transparency. * Flexible and motivated by mission-driven goals to improve patient outcomes.

Application Deadline: 2025-02-03