Head of Toxicology

The Role

At Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic, diverse, and innovative workplace where every individual’s contribution is vital.

We are seeking a highly accomplished and experienced biopharmaceutical professional to join us as a senior leader of the Toxicology line function. The seasoned incumbent will fulfill a key leadership role within our organization, responsible for building team capabilities, overseeing and advancing the toxicology function and interacting with leaders of multiple functions across the Research & Development organization to deliver on Moderna’s ambitious mission. The incumbent will play a critical role as an enterprise leader, proactively planning for and executing on an organizational design and team structure that enables the team to flexibly support programs across a diverse early- and late-stage pipeline. A track record of superior communication skills, innovative problem-solving skills that navigate complex challenges, and comfort working in a dynamic, fast-paced, cross-functional team environment are required.

Here’s What You’ll Do

In alignment with the corporate mindsets, provide strategic leadership and direction for and build capabilities of the Toxicology team to execute on Moderna's ambitious and dynamic agenda to deliver transformational medicines and vaccines to patients.

Apply in-depth knowledge of how toxicology disciplines (including but not limited to general toxicology, safety pharmacology, genotoxicity, developmental and reproductive toxicology, and carcinogenicity) integrate with other areas across the business and utilize business / market expertise to differentiate Moderna from the competition.

Evaluate toxicology challenges in a complex or fast-changing environment and direct the development of new or innovative solutions with in-depth analysis and interpretive thinking.

Lead and manage a team of toxicologists across a range of job levels and experience (may include people leaders), fostering a culture of innovation, collaboration, functional excellence, and continuous learning and development within the team, supporting career growth and professional development opportunities for team members.

In conjunction with platform and pipeline program teams and a cross-functional and integrated Nonclinical Drug Development Sciences team, provide strategic oversight on and coach / guide team members on the development of scientifically-sound toxicology strategies to provide expert support to discovery and development projects.

Accountable for the design, execution, and critical analysis of nonclinical safety in vitro and / or in vivo studies conducted in multiple species under the Toxicology umbrella via collaborative partnerships with study monitors and other partner line program representatives (e.g., pathology, DMPK, bioanalytical, operations, etc.). Accountable for toxicology assessments supporting extractable / leachable and contaminant risk assessments and / or impurity qualification.

Collaborate closely with and establish positive working relationships with leaders of / colleagues from other nonclinical disciplines (e.g., pathology, DMPK, bioanalytical, therapeutic and infectious disease research, study management & outsourcing, writing, strategic operations) to deliver on integrated nonclinical safety data packages for programs, as well as with clinical development and safety colleagues when interpreting nonclinical data as it pertains to active clinical pipeline programs.

Provide strategic advice to project teams and senior management including evaluation of conclusions and impact of study results on program and clinical / regulatory strategy.

Apply expert scientific and regulatory writing experience when critically reviewing, editing, and authoring submission application documents (INDs, CTAs, BLAs and MAAs) and health authority interaction documents (e.g., briefing documents, regulatory query responses) and integrate results with DMPK and pharmacology. Ensure alignment of toxicology with clinical development plans and regulatory strategies.

Oversee the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal / external partners and / or scientific groups.

Maintain extensive scientific awareness and presence internally and externally, leading initiatives to publish manuscripts and posters, present at scientific conferences and other scientific forums, engage with consultants and advisors in the field, as well as the scientific community at large.

In addition to serving as Head of the Toxicology line function, the incumbent may also serve as an independent contributor for a select number of discovery and / or pipeline programs as a Toxicology representative.

Here’s What You’ll Need (Minimum Qualifications)

PhD & 15 or more years spent overseeing aspects of nonclinical safety assessment activities in pharmaceutical development. Strong consideration will be given to those with experience in nucleic acid-based and nanoparticle modalities, immune-modulating therapeutics, oncology, and / or infectious disease vaccine drug development.

A distinguished reputation in the global scientific community as a Toxicology expert.

Experience serving in / managing colleagues serving in the capacity of a Toxicology representative on drug development programs in the pharmaceutical / biotechnology industry and corresponding experience in designing and executing nonclinical toxicology strategies and studies to support clinical development and marketing applications.

Experience in mentoring, coaching, and managing others on developing toxicology strategies.

Direct experience in writing, reviewing, and critiquing nonclinical sections of regulatory submission documents (e.g., INDs / CTAs / BLAs / MAAs, briefing documents, regulatory query responses) and interacting with regulatory agencies.

Familiarity with regulatory guidelines for the conduct of nonclinical safety studies to support regulatory filings.

Experience with and a passion for people management, team building, and creative solution seeking.

Outstanding written and verbal communication skills and the ability to develop and deliver clear and concise presentations for both internal and external stakeholders.

Attention to detail and quality, and ability to deliver work on time.

Demonstrated ability to work successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and / or strategic directions.

Experience in significantly impacting departmental and organizational initiatives that have shaped research strategies.

A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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, 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. 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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