Associate Director, Biomarker Statistics

The Role:

This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Associate Director of Clinical Biomarkers will serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans in clinical stage ID programs.  This position reports to Moderna’s Senior director of Clinical Biomarkers.  The role will work collaboratively across clinical teams to ensure strategy, planning, execution and data delivery of biomarker lab data for early and late phase infectious disease vaccine clinical trials conducted by Moderna.

Here’s What You’ll Do:

• Serve as the biostatistics leader and point-of-contact in multiple clinical development teams responsible for determining Clinical Biomarker study strategies and delivering results with high quality and on time. 

• Partner with a team of dedicated and senior Clinical Biomarker scientists on the science and bioanalytical assays for Moderna’s early and late phase infectious disease vaccine programs. Oversee biomarker plans and strategy with input from research and clinical leads for ID studies. Responsible to ensure assay labs complete appropriate development, qualification or validation of biomarker assays in order to execute the clinical biomarker plan on time and with good quality for ID clinical programs.

• Bring innovative statistical thinking and methodologies to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs.

• Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types. Serve as a primary point of contact for biomarker operations across ID teams, and with external collaborators, assay labs and CROs. Ensure timely and efficient delivery of all biomarkers operational aspects across multiple ID clinical trials

• Develop statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses 

• Plan, manage, and track biomarker related biostatistical activities, timelines, and resources and assure operational excellence 

• Support interactions with regulatory agencies and effectively address the statistical questions and requests regarding Biomarker endpoints 

• Review and/or author SOPs and/or work Instructions related to biostatistics practices. Develop and provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent form, IB and regulatory filings) and processes, and ensure collection, delivery and analysis of biosamples in compliance with these documents as well as GCP/ICH

• Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals 

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

• PhD (with at least 7 years pharmaceutical/biotechnology experience) in a related science with a focus on infectious disease.

• Solid experience in the application of biomarkers during development of assets required including experience with clinical translational research, development, validation and implementation of biomarkers in the ID space.

• Outstanding communication skills (verbal and written). 

• Strong working knowledge of relevant FDA, EU, ICH guidelines and regulations.

• Ability to manage multiple projects in a fast-paced environment.

• Experience working with CROs, vendors, and relationship management Strong communication and project management skills

• Deep understanding of the regulatory expectations for pivotal biomarkers in clinical trials

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

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific 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 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 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 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. We’re 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) 

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