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.

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.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• 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. 

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. 

Our Working Model 

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. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

Equal Opportunities

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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

Accommodations

We’re 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 [email protected]. 

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens, U.S. lawful permanent residents, asylees, or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered, contingent on the company’s ability to obtain any required export control license.

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