Senior Manager Clinical Scientist – Oncology

Overview

• Drive the strategic development and execution of oncology clinical studies, ensuring adherence to regulatory standards and scientific integrity.
• Collaborate with multidisciplinary teams to design innovative clinical programs and achieve project milestones effectively.
• Provide expert scientific guidance to support early and late-stage drug development initiatives.
• Contribute to advisory boards, program meetings, and data monitoring activities to ensure study success.
• Maintain in-depth knowledge of therapeutic areas, disease biology, and drug mechanisms to inform study design.
• Author and review clinical trial protocols, amendments, and regulatory documents with precision and compliance.
• Ensure compliance with FDA, EMEA, ICH, and GCP guidelines in all clinical safety practices.
• Perform clinical data review and safety monitoring to uphold patient safety and study integrity.

Key Responsibilities & Duties

• Lead clinical study teams to align project goals with organizational objectives and regulatory standards.
• Develop and refine clinical trial protocols and amendments, integrating scientific insights and innovations.
• Conduct quality reviews of clinical documents and regulatory submissions to ensure accuracy and compliance.
• Monitor clinical trial data for consistency, accuracy, and adherence to safety standards.
• Collaborate with medical directors to design and implement effective clinical programs.
• Support regulatory submissions with comprehensive clinical documentation and analysis.
• Identify potential risks in clinical studies and develop proactive mitigation strategies.
• Promote standardized clinical data review practices across assigned studies to ensure consistency.

Job Requirements

• Master’s degree in life sciences or healthcare; advanced degree preferred (PhD/MD/PharmD).
• Minimum 7 years of experience in pharmaceutical clinical drug development; 8 years preferred.
• Comprehensive knowledge of drug development processes, GCP guidelines, and clinical research methodologies.
• Proven expertise in clinical trial process improvements and cross-functional team collaboration.
• Exceptional analytical, management, and problem-solving skills in clinical research settings.
• Proficiency in medical writing and preparation of regulatory documents.
• Strong understanding of therapeutic disease areas, drug mechanisms, and clinical manifestations.
• Ability to effectively influence and collaborate within teams and across organizational functions.