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 individual’s 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, fast-paced, cross-functional team environment are required.

Here’s What You’ll Do

• In conjunction with development program teams and a cross-functional and integrated nonclinical team, develop toxicology strategies and provide expert support to development projects, particularly those in early- and late-stage clinical development.

• Serve as functional line representative on development program core teams  and help lead cross-functional 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 late-stage 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 cross-company 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.

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

• PhD & 10 years of scientific experience OR Master’s degree & 15 years of scientific experience OR Bachelor’s 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