Senior Director, Clinical Scientist

The Role:

Moderna is seeking an experienced Clinical Sciences Team Leader to build and expand its clinical science capabilities. This role requires a strong track record of successfully building business capabilities in the biotech or pharmaceutical industry, advanced scientific and line function/team leadership skills, and a deep commitment to transforming patients lives.

Heres What Youll Do:

Establish Clinical Sciences as a valued scientific leadership line function

Hire, onboard, train, mentor, develop, and manage a high-functioning group of clinical scientists that are seen as valued scientific partners in the design and execution of clinical programs

Partner with critical Functional Line Leaders (Study Physicians, Clinical Operations, Biometrics, Safety) to define cross-functional ways of working with Clinical Sciences

Setup ways of working, standards, and tools for Clinical Scientists to ensure clinical relevancy and interpretability of data through the authorship of core study documents (e.g., protocols, informed consent forms, eCRFs) and the creation & execution of critical study plans (e.g., medical monitoring and data cleaning plans)

Serve as point of contact and escalation for setting up and managing outsourced scopes of work to Contract Research Organizations through partnership with Development Operations

Serve as the accountable person for the quality of clinical trial data for clinical review and interpretation to achieve regulatory reporting/filing milestones

Partner across development line functions to deliver well executed clinical programs

Partner with Program and Clinical Leadership to plan and resource clinical programs effectively

Oversee the quality and effectiveness of the Clinical Scientist Team, including their:

Collaboration with Clinical Operations, Study Team & Program Leadership in the planning and execution of clinical studies

Effective Scientific Authorship of protocols, consent forms, analysis plans and other key scientific study documents

Timely and High-Quality Data Review of data listings, data coding, cohort profiles, and analyses

Coordination of clinical and safety oversight by Study Physicians and Pharmacovigilance to ensure study treatment discontinuation or other safety decisions are made per protocol

Oversight of database

Delivery of Relevant and Timely Data Analyses, Reporting & Presentation to meet timelines for investigator & monitoring committee meetings, regulatory actions, and to make timely program decisions regarding study objectives

Planning and Execution of Protocol/Scientific Training of Investigators, Site Management/Monitors, and other key study personnel

Facilitation of scientific content and discussion for Advisory Board / Scientific Committee Meetings, and with Investigators and Site Study Staff throughout the lifecycle of the program

Serve as a Clinical Scientist to address study demands as needed, acting as player coach, taking on study level responsibility as needed

Heres What Youll Bring to the Table:

Advanced Degree in a Scientific discipline (i.e. M.S, Ph.D. or Pharm.D.) is required.

A minimum of 10 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required

The individual must have demonstrated ability to lead a team; track record of building a team is a plus.

Extensive experience in Therapeutics Development Oncology or Rare disease experience preferred, and across different therapeutic areas is a plus

Track record of successfully managing pivotal phase 3 programs, including registrational database locks; submission and HA inspection experience is a plus

Experience with CRO oversight

Track record of leading development and implementation of new processes and roles

Track record of working with a diverse cross functional team, with ability to influence and align with key cross functional stakeholders

Proven leadership in clinical evaluation projects, including the development of protocols, case report forms, informed consent, study initiation, and monitoring.

Exceptional abilities in data integrity, exploration, analysis, and presentation.

Excellent written communication, oral communication, and presentation skills are required.

Ability to travel up to 30% is required.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class 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 peopleare 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 in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office 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.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free 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 proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

-