Director, Clinical Sciences, Oncology

About the role

This role supports Oncology Therapeutic programs, specifically focusing on the Clinical Development Lead in the direction, execution, and evaluation of Phase 1-3 clinical studies. The principal 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 the oversight of clinical studies, including leading studies with oversight from the Clinical Development Lead.
• Support managing study sites for safety decisions aligned with the protocol.
• Design and implement clinical study parameters to minimize operational risk and improve site performance and efficiency.
• Participate in inspection readiness activities for audits and regulatory inspections.
• Develop and execute strategies for Investigator Meetings, investigator engagement, and Advisory Board meetings.
• Train and educate junior Clinical Science personnel.
• Drive the evolution of the clinical science role and support process updates.
• Engage 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.
• Significant experience with clinical study design and protocol development.
• Significant experience with ensuring data integrity, data analysis, and data presentation.
• Excellent written and oral communication, presentation skills, and capability to contribute to both early and late-stage clinical development programs.
• The ability to travel up to 15% for work with study sites and attend scientific congresses.

Qualifications

• A PhD, PharmD, Masters’, or advanced nursing degree with significant scientific and clinical oncology knowledge.
• Pharmaceutical/biotechnology company experience.
• A minimum of 10 years of clinical development experience.
• Ability to work in a team environment.

Skills

• Strong scientific and clinical oncology knowledge.
• Experience with regulatory standards and clinical study documents.
• Effective communication and collaboration skills.
• Leadership and project management abilities.
• Ability to manage and analyze clinical data.
• Experience with clinical trial design and execution.

Benefits

Competitive healthcare, family planning benefits, generous paid time off, savings and investments, and location-specific perks and extras. The salary range for this role is $183,800.00 - $330,300.00. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities. Moderna is an E-Verify employer in the United States. We consider qualified job applicants regardless of criminal histories, consistent with legal requirements. Accommodations. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice. This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.