Principal Scientist, Toxicology

The Role:

Principal Scientists within the Toxicology department are part of a highly collaborative team that provide a range of functions supporting the nonclinical safety evaluation of Moderna Therapeutics and Vaccines. A primary function of the Principal Scientist is to serve as a nonclinical safety representative on multi-disciplinary drug development teams to enable progression of drug candidates from early discovery through development. In this function, the Principal Scientist will design, execute, and interpret non-clinical safety studies conducted in multiple species via collaborative partnerships with study monitors and other cross functional program representatives (e.g., DMPK, bioanalytical, etc.) and will ensure that all associated study reports are written with high quality and adhere to Moderna/regulatory guidelines. The Principal Scientist will also be heavily involved in regulatory submission writing to support clinical development of drug candidates. Principal Scientists operate as a leader within the department, providing a high level of scientific creativity to offer solutions to problems and mentorship and guidance to other members of the team. The successful candidate must have the ability to multi-task and function effectively in a fast-paced environment, be capable to work independently, and show the ability to enlist the expertise of subject matter experts when necessary to lead the conversation. The Principal Scientist will maintain extensive scientific awareness and presence internally and externally, 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.

Heres What Youll Do:

• Serve as a toxicology representative on discovery/platform or development project teams and initiate and proactively define toxicology strategies in conjunction with the toxicology team, program teams, and the Nonclinical Sciences team to meet program goals.

• Provide expert support to discovery and development projects to support clinical development of multiple therapeutic indications.

• Serve as a subject matter expert and provide leadership in a specific area of research (e.g., genetic or reproductive toxicology, safety pharmacology, early safety discovery screening).

• Evaluate new targets for potential toxicological liabilities.

• Design and interpret toxicology data from investigative, non-GLP, and GLP-compliant toxicology studies to support clinical development

• Review, summarize, and integrate complex data sets across multiple disciplines

• Summarize and communicate nonclinical safety data for project teams, portfolio management, internal /external partners and/or scientific groups.

• Collaborate with Study Monitors and contribute to high quality toxicology reports and tabulated summaries according to internal and regulatory guidelines.

• Provide toxicology support for regulatory submissions and interactions with health authorities, including the authoring of nonclinical safety sections of US and international regulatory applications and help resolve nonclinical safety queries.

• Interact cross functionally with DMPK, Bioanalytical, Pharmacometrics & Modeling, Research, Project Management, Regulatory, Clinical and Manufacturing.

• Author scientific reports or publications and represent Moderna at external meetings/consortia.

Heres What Youll Bring to the Table:

• Doctorate degree & 7 years of scientific experience OR Masters degree & 10 years of scientific experience OR Bachelors degree & 15 years of scientific experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector.

• Have working knowledge of drug discovery process. Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings.

• Experience in writing and reviewing regulatory documents and preparation of briefing documents to support interactions with global regulatory authorities.

• Experience with being a member of and/or leading cross-functional teams and capability to build productive cross-functional collaborations within and external to Moderna.

• Experience working with multiple therapeutic modalities and indications in drug development.

• Experience working with Contract Research Organizations.

• Ability to develop and deliver clear and concise presentations for both internal and external meetings.

• Outstanding written and verbal communication skills

• Ability to multi-task and quickly change priorities

• Candidate will be curious in exploring new path for drug discovery, bold in proposing creative experimental designs and ideas. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes

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 winter shut down
  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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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