Director, Clinical Sciences, Oncology

About the Role Director, Clinical Sciences, Oncology will support Oncology Therapeutic programs, directly assisting the Clinical Development Lead in the direction, execution and evaluation of Phase 1-3 clinical studies. The principal responsibility is ensuring comprehensive data quality of clinical studies to support internal governance decisions and regulatory submissions. What You'll Do

• In conjunction with the Clinical Development Lead and the broader clinical development team, contribute to regulatory and clinical program strategy, trial design and study execution.
• Author and review clinical study documents in compliance with regulatory standards, including clinical protocols, informed consent documents, Development Safety Update Reports DSUR, and clinical components of Investigator Brochures, INDs and marketing applications.
• Collaborate with the Clinical Development Lead in the oversight of clinical studies; may lead a clinical study with oversight from the Clinical Development Lead to provide clinical study leadership, review and interpretation of clinical data, and ensure timely execution of deliverables in collaboration with internal and external partners.
• Perform and coordinate clinical data review and analysis of study data, including review of case report forms, data listings, medical coding and patient profiles to ensure proper and complete verification of clinical data.
• In collaboration with the Clinical Development Lead and Clinical Safety & Pharmacovigilance, support managing study sites to ensure safety decisions are made in alignment with the protocol.
• Collaborating with Clinical Operations, participate in the start-up and execution of global clinical studies to ensure on-schedule site activation and subject enrollment.
• Design and implement clinical study parameters to minimize operational risk and increase study site performance and efficiency.
• Contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
• Develop the strategy and drive the messaging and associated content for Investigator Meetings, investigator engagement and Advisory Board meetings.
• Responsible for training and educating junior Clinical Science personnel.
• Support and help drive the evolution of the clinical science role at Moderna and support process updates.
• Participate in Development workstreams related to the clinical trial delivery operating model. What We're Looking For
• A personal and professional commitment to the highest personal and ethical standards; a high-performing, self-motivated and energetic individual with outstanding scientific acumen.
• Experience in oncology clinical development, particularly Phase 1-3, with a focus on data quality and regulatory submissions.
• Ability to author and review regulatory documents including protocols, DSURs, Investigator Brochures components, INDs and marketing applications.
• Demonstrated leadership and collaboration with internal and external partners and cross-functional teams.
• Strong analytical skills for clinical data review, data listings, medical coding and patient profiling.