Scientific Director 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 individuals contribution is vital.

In this role you will serve as a toxicology subject matter expert and functional line representative on drug development program teams to enable drug candidates from discovery through marketing. You will apply deep knowledge and technical expertise in regulatory toxicology strategy dossier writing and health authority interactions to drive development program strategy and define new scientific directions of the department with leadership. Strong communication skills and comfort working in a dynamic fastpaced crossfunctional team environment are required.

Heres What Youll Do

• In conjunction with development program teams and a crossfunctional and integrated nonclinical team develop toxicology strategies and provide expert support to development projects particularly those in early and latestage clinical development.

• Serve as functional line representative on development program core teams and help lead crossfunctional nonclinical subteams.

• Design execute and critically analyze nonclinical in vitro and/or in vivo safety studies conducted in multiple species via collaborative partnerships with study monitors and other partner line program representatives (e.g. drug metabolism and pharmacokinetics DMPK bioanalytical program management study management and outsourcing etc..

• Lead finalization of toxicology study reports and manage the tabular presentation of data in accordance with CTD format.

• Review summarize and integrate complex datasets across all nonclinical safety disciplines (toxicology safety pharmacology genotoxicity developmental & reproductive toxicology immunotoxicology etc) for project teams portfolio management senior leaders internal/external partners and/or scientific groups.

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

• Apply expert knowledge when reviewing editing and/or authoring regulatory submissions and health authority interaction documents (e.g. briefing documents regulatory query responses) for assigned programs and integrate results with DMPK and pharmacology. Represent toxicology and/or integrated nonclinical functions with health authorities to support early and latestage clinical development and marketing applications (BLA MAA).

• Collaborate closely with Research Regulatory Manufacturing and Clinical to deliver on company objectives. Work closely with Clinical colleagues to ensure toxicology coverage for clinical trial designs and marketed product dosing regimens.

• Collaborate with the Head of Toxicology and other partner line leaders to positively influence the department and organization.

• Regularly operate as a leader by mentoring and having direct and/or matrix management responsibilities for other toxicology program representatives by providing scientific guidance and input and by leading by example.

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

• Serve as a resource for the department and project teams proactively keeping colleagues and leadership updated with industry trends.

Heres What Youll Need (Minimum Qualifications)

• PhD & 10 years of scientific experience OR Masters degree & 15 years of scientific experience OR Bachelors degree & 20 years of scientific experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector.

• Experience 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 safety strategies and studies to support clinical development.

• Extensive experience in writing and reviewing nonclinical modules for regulatory submissions (e.g. multiple INDs/CTAs and preferably BLA/NDA/MAA).

• Experience in responding to health authority queries and presenting to authorities in person or virtually.

• Demonstrated leadership in developing regulatory toxicology/safety strategies that influence the development of programs across multiple therapeutic modalities (e.g. small molecules and biotherapeutics)

• Experience in mentoring coaching and/or managing others on developing toxicology/regulatory strategies.

• Broad knowledge of GLP regulations and ICH/FDA regulatory guidelines for the conduct of nonclinical safety studies to support regulatory filings.

• Experience working with Contract Research Organizations.

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

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

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

Heres What Youll Bring to the Table (Preferred Qualifications)

• Experience in significantly impacting departmental and organizational initiatives that have shaped research strategies and/or leading risk mitigation teams to derisk nonclinical findings or understand crossspecies translation of clinical safety events.

• Strong leadership skills with Managerial/direct supervisory experience

• Experience with discovery toxicology infectious disease (vaccines) rare disease oncology autoimmune diseases and/or gene therapy.

• Experience with preparing authoring and reviewing marketing application regulatory dossiers (BLA MAA NDA).

• A desire to make an impact as part of a highgrowth 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. 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)