Scientific Director, Discovery & Platform Lead - Toxicology
Company: Moderna, Inc.
Location: Cambridge
Posted on: August 3, 2022
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Job Description:
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 strategiesCollaborate 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 formatsEnsure study documentation and
reporting that adheres to departmental policies and regulatory
expectationsEffectively communicate orally and/or via written
documents internally and, when needed, to regulatory
authoritiesProvide strategic advice to program teams and senior
management including evaluation of conclusions and potential impact
of toxicology results on program and clinical/regulatory
strategyProactively plan platform toxicology strategies that can be
used to support clinical development and marketing of drug
candidatesMentor and have direct and/or matrix management
responsibilities by providing scientific guidance and input and by
leading by exampleServe as a resource for the department and
project teams, proactively keeping colleagues and leadership
updated with industry trendsCollaborate with the Head of Toxicology
and other partner line leaders to positively influence the
department and organizationHere'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 modalitiesExperience in the
report generation of early discovery safety data used in health
authority dossiersFamiliarity with GLP regulations and ICH/FDA
guidelines for the conduct of toxicology studies to support
regulatory filingsExperience working with Contract Research
OrganizationsAbility to develop and deliver clear and concise
presentations for both internal and external meetingsOutstanding
written and verbal communication skillsAbility to multi-task and
quickly change prioritiesModerna 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 optionsFlexible Spending Accounts for medical
expenses and dependent care expensesLifestyle Spending Account
funds to help you engage in personal enrichment and self-care
activitiesFamily care benefits, including subsidized back-up care
options and on-demand tutoringFree premium access to fitness,
nutrition, and mindfulness classes Exclusive preferred pricing on
Peloton fitness equipmentAdoption and family-planning
benefitsDedicated care coordination support for our LGBTQ+
communityGenerous paid time off, including:Vacation, sick time and
holidaysVolunteer time to participate within your
communityDiscretionary winter shut down Paid sabbatical after 5
years; every 3 years thereafterGenerous Paid Leave offerings,
including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning toolsModerna-paid Life, LTD and
STD insurance coverages, as well as voluntary benefit
optionsComplimentary concierge service including home services
research, travel booking, and entertainment requestsFree parking or
subsidized commuter passesLocation-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 ModernaIn 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. #LI-JW2
Keywords: Moderna, Inc., Cambridge , Scientific Director, Discovery & Platform Lead - Toxicology, Executive , Cambridge, Massachusetts
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