Associate Director Clinical Scientist Oncology

Overview

• Lead the planning, execution, and evaluation of clinical studies within oncology programs.
• Collaborate with cross-functional teams to ensure the integrity of study data and compliance with regulatory guidelines.
• Provide scientific expertise to design and deliver clinical studies and programs effectively.
• Contribute to program team meetings, advisory boards, and safety monitoring activities.
• Develop and maintain a deep understanding of therapeutic areas and drug candidates.
• Assist in authoring and reviewing clinical trial protocols, amendments, and regulatory documents.
• Perform clinical data review and ensure patient safety through monitoring activities.
• Promote consistent clinical data review techniques across assigned studies.

Key Responsibilities & Duties

• Lead clinical study teams and contribute to global clinical sub-teams.
• Participate in collaborative activities with various departments and external committees.
• Support initiation and execution of clinical research studies for early and late-stage assets.
• Author and review clinical trial protocols, informed consents, and clinical study reports.
• Ensure compliance with FDA, EMEA, ICH, and GCP guidelines.
• Perform quality reviews and support development of regulatory documents.
• Identify critical risks and develop mitigation strategies for clinical studies.
• Provide first-line clinical data review and ensure consistency across studies.

Job Requirements

• Master’s degree in life sciences or healthcare; advanced degrees preferred (PhD/MD/PharmD).
• Minimum of 7 years of pharmaceutical clinical drug development experience; 8 years preferred.
• Proven knowledge of drug development processes, study design, and clinical research methodologies.
• Strong management, interpersonal, and problem-solving skills.
• Experience with regulatory requirements and ICH/GCP guidelines.
• Demonstrated ability to influence within teams and across functions.
• Considerable organizational awareness and cross-functional collaboration experience.
• Proficiency in medical writing and clinical trial process improvements.