Senior Manager Clinical Scientist – Oncology

Overview

• Lead clinical study development and execution in oncology, ensuring data integrity and compliance with regulatory guidelines.
• Collaborate with cross-functional teams to design and deliver clinical programs effectively.
• Provide scientific expertise to support early and late-phase drug development projects.
• Contribute to program meetings, advisory boards, and data monitoring activities.
• Develop and maintain understanding of therapeutic areas, disease biology, and drug mechanisms.
• Author and review clinical trial protocols, amendments, and regulatory documents.
• Ensure compliance with FDA, EMEA, ICH, and GCP guidelines in clinical safety practices.
• Perform clinical data review and safety monitoring to ensure patient safety and study integrity.

Key Responsibilities & Duties

• Coordinate and lead clinical study teams, ensuring alignment with project goals.
• Develop clinical trial protocols and amendments, incorporating scientific insights.
• Perform quality reviews of clinical documents and regulatory submissions.
• Monitor clinical trial data for accuracy and compliance with safety standards.
• Collaborate with medical directors to design and execute clinical programs.
• Support regulatory submissions with detailed clinical documentation and analysis.
• Identify risks and develop mitigation strategies for clinical studies.
• Promote consistent clinical data review practices across assigned studies.

Job Requirements

• Bachelor’s degree required; advanced degree in life sciences or healthcare preferred (PhD/MD/PharmD/MSc).
• Minimum 7 years of experience in pharmaceutical clinical drug development; 8 years preferred.
• Proven knowledge of drug development processes, GCP, study design, and clinical research methodology.
• Experience with clinical trial process improvements and cross-functional collaboration.
• Strong analytical, management, and problem-solving skills.
• Proficiency in medical writing and regulatory document preparation.
• Knowledge of therapeutic disease areas, drug mechanisms, and clinical manifestations.
• Ability to influence within teams and across functions effectively.