Director, Clinical Sciences, Oncology

About the role

This role supports Oncology Therapeutic programs, focusing on Phase 1-3 clinical studies. The primary responsibility is ensuring comprehensive data quality for clinical studies to support internal governance and regulatory submissions.

Responsibilities

• Contribute to regulatory and clinical program strategy, clinical trial design, and clinical study execution.
• Author and review clinical study documents in compliance with regulatory standards, including clinical protocols, informed consent documents, DSURs, and Investigator Brochures, INDs, and marketing applications.
• Collaborate with the Clinical Development Lead in overseeing clinical studies.
• May lead a clinical study with oversight from the Clinical Development Lead, providing clinical study leadership, reviewing and interpreting clinical data, and ensuring timely execution of deliverables.
• Perform and coordinate clinical data review and analysis, including reviewing case report forms, data listings, medical coding, and patient profiles to ensure proper and complete verification of clinical data.
• Support managing study sites to ensure study treatment discontinuations or other safety decisions align with the protocol.
• Collaborate with Clinical Operations to start-up and execute global clinical studies, ensuring on-schedule site activation and subject enrollment.
• Design and implement clinical study parameters to minimize operational risk and enhance study site performance and efficiency.
• Collaborate on and contribute to inspection readiness activities supporting audits and regulatory inspections related to clinical trial conduct.
• Develop and drive the strategy for Investigator Meetings, investigator engagement, and Advisory Board meetings.
• Train and educate junior Clinical Science personnel.
• Support and drive the evolution of the clinical science role at Moderna and process updates.
• Participate in Development workstreams related to the clinical trial delivery operating model.

Requirements

• A personal and professional commitment to the highest personal and ethical standards.
• A high-performing, self-motivated, and energetic individual with outstanding scientific and clinical oncology knowledge.
• A history of successfully operating in a matrix environment and demonstrating highly developed interpersonal and communication skills.
• Capability to contribute to both early and late-stage clinical development programs, with close collaboration with Drug Discovery, Translational Medicine, Regulatory Affairs, Biostatistics, Medical Affairs, and Commercial.

Qualifications

• A minimum of 10 years of clinical development experience within a pharmaceutical/biotechnology company.
• Significant experience with clinical study design and protocol development.
• Significant experience with ensuring data integrity, data analysis, and data presentation.
• Excellent written communication, oral communication, and presentation skills.
• Ability to travel up to 15% required for travel to work with study sites and attend national and international scientific congresses.

Benefits

Competitive healthcare, voluntary benefit programs, access to fitness, mindfulness, and mental health support, family planning benefits, generous paid time off, and savings and investment options. The salary range for this role is $183,800.00 - $330,300.00. Moderna is an E-Verify employer in the United States and is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.