Director Clinical Science Oncology

The Role:

This role will support Oncology Therapeutic programs specifically supporting the Clinical Development Lead in the direction and evaluation of Phase 13 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.

Heres What Youll 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 .

• 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 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 startup and of global clinical studies to ensure onschedule 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.

Heres What Youll Need:

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

• A highperforming selfmotivated and energetic individual who demonstrates outstanding scientific and clinical oncology knowledge that results in the conduct of wellexecuted 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 latestage clinical development programs. This will involve close with Drug Discovery Translational Medicine Regulatory Affairs Biostatistics Medical Affairs and Commercial.

Heres What Youll 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 LEEDcertified HQ in Cambridge MA or Princeton NJ office and is expected to be inoffice 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. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.

• Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to wellbeing with access to fitness mindfulness and mental health support
• Lifestyle Spending Accounts to personalize your wellbeing journey
• Family planning and adoption benefits
• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
• Savings and investment opportunities
• Locationspecific perks and extras

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a worldclass team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit modernatx/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law.

Moderna is an EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

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 . (EEO Employer)