Director, Clinical Science, Oncology

The Role:       

This role will support Oncology Therapeutic programs, specifically supporting the Clinical Development Lead in the direction, execution and evaluation of Phase 1-3 clinical studies. The principal responsibility for this role is ensuring the comprehensive data quality of clinical studies to support internal governance decisions and support regulatory submissions.

Here’s What You’ll Do:

• In conjunction with the Clinical Development Lead and the broader clinical development team, 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, 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 the proper and complete verification of clinical data.

• In collaboration with the Clinical Development Lead and Clinical Safety & Pharmacovigilance, support managing study sites to ensure that study treatment discontinuation or other 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 of a clinical trial.  Design and implement clinical study parameters to minimize operational risk and increase study site performance and efficiency. Collaborate on and 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.

• Responsibility 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.

Here’s What You’ll Need: 

• A personal and professional commitment to the highest personal and ethical standards. 

• A high-performing, self-motivated and energetic individual who demonstrates outstanding scientific and clinical oncology knowledge that results in the conduct of well-executed clinical research.

• A history of successfully operating in a matrix environment and the demonstration of highly developed interpersonal and communication skills.   

• Capability to successfully contribute to both early and late-stage clinical development programs. This will involve close with Drug Discovery, Translational Medicine, Regulatory Affairs, Biostatistics, Medical Affairs and Commercial. 

Here's What You’ll Bring to the Table:

• The individual must have the demonstrated ability to successfully work in a team environment.

• This role is best suited for candidates holding a PhD, PharmD, Masters’ or advanced nursing degree with significant scientific and clinical oncology knowledge, pharmaceutical/biotechnology company experience and a comprehensive knowledge of drug development.

• 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.

• This role is based in our new LEED-certified HQ in Cambridge, MA, or Princeton, NJ office and is expected to be in-office 70% of the time with flexibility to work from home up to 30%.

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.