Scientific Director, Toxicology

Company: Moderna Therapeutics Inc.
Location: Cambridge
Posted on: November 6, 2024

Job Description:

The RoleAt 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 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 fast-paced 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.Here's What You'll 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 cross-species translation of clinical safety events.
    • Strong leadership skills with Managerial/direct supervisory experience.
    • Experience with discovery toxicology, infectious disease (vaccines), rare disease, oncology, auto-immune 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 high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.About ModernaSince 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 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 . (EEO/AAP Employer)
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Keywords: Moderna Therapeutics Inc., Portland , Scientific Director, Toxicology, Executive , Cambridge, Maine