Scientific Director, Discovery & Platform Lead - Toxicology

The Role:

Reporting to and collaborating with the Head of Toxicology, the Scientific Director, Discovery and Platform Toxicology Lead, will have overall responsibility for leading discovery screening efforts and early toxicology strategies to enable data-driven safety decisions regarding the advancement of novel lipid nanoparticles (LNPs) and/or mRNA sequence elements proposed for use in vaccine and therapeutic development programs. The Scientific Director will be responsible for establishing toxicology and non-clinical safety workflows (e.g., in vitro, ex vivo, and/or in vivo) to identify hazards across multiple target organs and have the opportunity to span both investigational and compound/LNP profiling to facilitate designing and developing the best-in-class LNPs for Moderna vaccines and medicines. The Scientific Director will be considered a subject matter expert (SME) in early discovery toxicology, with experience in screening cascades used to rank order drug candidates (e.g., cytotoxicity, mitochondrial toxicity, secondary pharmacology screening, in silico mutagenicity assessments, and/or bile salt export pump toxicity), will be skilled at designing in vitro and in vivo experiments to understand the translation of data across research formats, and will ensure study documentation and reporting that adheres to departmental policies and regulatory expectations.  The Scientific Director will collaborate extensively with other leaders and team members in Toxicology to proactively plan platform toxicology work in the Discovery and Platform space that can be used to support development programs. The Scientific Director will also be responsible for establishing and maintaining strong relationships with other functional line stakeholders (Platform Chemistry and Formulation Discovery, Platform Research) to achieve program and corporate goals. The successful candidate must have the ability to multi-task and function effectively in a fast-paced environment, have experience influencing across all career levels, be capable of conducting work independently, and show the ability to enlist the expertise of subject matter experts when necessary to lead the conversation.  The Scientific Director 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.  The Scientific Director will have direct and/or matrixed management responsibilities for colleagues within the Toxicology team.

Here’s What You’ll Do:

• Overall scientific oversight of discovery screening efforts and early toxicology strategies

• Collaborate with functional line stakeholders within/external to the Toxicology team to design in vitro and in vivo experiments to understand the translation of safety data across research formats

• Ensure study documentation and reporting that adheres to departmental policies and regulatory expectations

• Effectively communicate orally and/or via written documents internally and, when needed, to regulatory authorities

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

• Proactively plan platform toxicology strategies that can be used to support clinical development and marketing of drug candidates

• Mentor and have direct and/or matrix management responsibilities by providing scientific guidance and input and by leading by example

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

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

Here’s What You’ll Bring to the Table:

• Doctorate degree & 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 as a leader in discovery screening efforts and early toxicology strategies that influence the development of programs across multiple therapeutic modalities

• Experience in the report generation of early discovery safety data used in health authority dossiers

• Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings

• 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

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 person’s 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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