Associate Director, Clinical Sciences

Role Summary

Associate Director, Clinical Sciences supporting oncology clinical trials within a cross-functional clinical matrix team. Responsible for designing, executing, and delivering trials, optimizing processes, identifying risks with mitigation, and maintaining data integrity to meet regulatory and ethical standards. Involves protocol development, trial conduct, collaboration with internal and external experts, and mentorship within the clinical science team.

Responsibilities

• Work collaboratively with the clinical science team to help inform program strategy for designated clinical trials and compounds and play a role in developing comprehensive clinical development plans.
• Design clinical trials to assess the safety and effectiveness of investigational oncology drugs, covering protocol development, patient population identification, endpoint selection, and optimal study design.
• Lead or co-author and review essential clinical and regulatory documentation as appropriate, including protocols, informed consent forms (ICF), investigator brochures (IB), annual safety updates, study reports, and regulatory submissions required for compound registration and commercialization, etc.
• Oversee clinical trial execution, ensuring adherence to protocols, regulatory standards, and ethical guidelines. Monitor study progress, review data, and manage adverse event reporting and resolution.
• Work with the clinical development team to address regulatory and health authority inquiries and maintain compliance with applicable guidelines.
• May contribute to the planning and execution of the Clinical Development Plan, Integrated Evidence Plan, and clinical aspects of the Target Product Profile (TPP).
• Assist in organizing and participating in study/ program related meetings, such as Investigator Meetings, KOL meetings, Data Monitoring Committee meetings, for investigator meetings, CRO/CRA training sessions, and site initiation visits (SIVs) as needed etc.
• Collaborate with data management for the development and review of electronic case report forms (eCRFs) and associated completion guidelines, UATs, and oversee the deployment of data capture tools.
• Conduct thorough clinical data reviews, identify trends and insights, and support interim analyses, database lock activities, and the resolution of scientific and medical issues during the study lifecycle.

Qualifications

• Bachelor's degree in life sciences, healthcare, or nursing required; advanced degree preferred.
• At least 8 years of clinical development experience, preferably in oncology or immuno-oncology.
• Comprehensive understanding of Good Clinical Practice (GCP) and all phases of drug development (Phase 1–3).
• Demonstrated expertise in planning, organizing, and executing global clinical studies within a pharmaceutical company, CRO, or academic setting.
• Skilled at fostering collaboration across cross-functional teams, stakeholders, and external partners to drive project success and support strategic objectives.
• Strong foundation in clinical data collection and reporting, with proficiency in systems and tools (e.g., EDC platforms, Excel) for data analysis and reporting. Experience in process and tool optimization is highly desirable.
• Proven ability to work effectively in a matrix environment and influence stakeholders without direct authority.

Skills

• Clinical trial design and execution
• Regulatory documentation and submissions
• Cross-functional collaboration
• Data management and analysis (EDC, MS Excel)
• Regulatory compliance and GCP

Education

• Bachelor's degree in life sciences, healthcare, or nursing; advanced degree preferred