Dir. Clinical Scientist

Job Title: Dir. Clinical Scientist

Job Number: 35726

Location: , 

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.