Director/Senior Director, Regulatory Affairs, Therapeutics
Company: Mammoth Biosciences
Location: Brisbane
Posted on: October 22, 2024
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Job Description:
Mammoth BioSciencesOPPORTUNITYMammoth is hiring aDirector/Sr.
Director, Regulatory Affairs, Therapeutics, to lead the regulatory
activities of our growing CRISPR-based therapeutic programs as we
bring them from concept to market. This role will be responsible
for coordinating all aspects of regulatory strategy, interactions,
and filings. The Director/Sr. Director will oversee and partner
with several external consultants in the short term. In the longer
term, they will be responsible for building out the regulatory
function for the company. This is a leadership position that will
play a critical role in the successful development of the Mammoth
therapeutic candidates. The role will report into the SVP of
Translational Science.
KEY RESPONSIBILITIESLead, define and manage the strategic
regulatory direction for Mammoth's pipelineEstablish the regulatory
pathway to IND filing in complex programs using a novel gene
editing technologyCollaborate with various regulatory consultants,
clinical advisory board members, and board members to maintain
regulatory knowledge of US and EUInterface with CMC, nonclinical
research and clinical research personnel and help keep them
apprised of new regulations, standards, policies, and guidance
issued by regulatory authoritiesServe as a liaison between the
company and regulatory agenciesMaintain real time understanding of
Mammoth's target patient populationDevelop and coordinate high
quality submissions for global clinical trials REQUIRED
QUALIFICATIONSBachelor's degree in life sciencesMinimum of 10+
years of experience in the biotechnology and/or biopharmaceutical
industry (Master's degree with 8+ years of experience or PhD with
6+ years of experience); Sr. Director: Minimum of 12+ years of
experience in the biotechnology and/or biopharmaceutical industry
(Master's degree with 10+ years of experience or PhD with 8+ years
of experience). Minimum of 7 years in a Regulatory capacity with
experience in drug developmentExperience with US and clinical trial
submissions through with CBER/OTAT or ex-US equivalentProven track
record with regulatory agenciesStrong project management skills and
drive for excellenceExperience with gene therapy products
regulatory requirementsProven success interacting efficiently with
Preclinical Research, CMC, and ClinicalAbility to be onsite a
minimum of 2-3x/ per week from a reasonable commuting distance
within the Bay Area PREFERRED QUALIFICATIONSAdvanced degree in life
sciencesCreative problem solverBENEFITSCompany-paid
health/vision/dental benefitsUnlimited vacation and generous sick
timeCompany-sponsored meals and snacksWellness, caregiver and
ergonomics benefits401(k) with company matchingBase Salary Range: $
205,000 - $260,000Actual base salary will be determined by relevant
professional experience, applicable skills, and internal equity.
COMPANYMammoth Biosciences is a biotechnology company focused on
leveraging its proprietary ultracompact CRISPR systems to develop
long-term curative therapies, as well as other applications such as
decentralized precision diagnostics. Founded by CRISPR pioneer and
Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and
Lucas Harrington, the company's ultracompact proteins are designed
to enable in vivo gene editing in difficult to reach tissues
utilizing both nuclease applications and new editing modalities
beyond double stranded breaks, including base editing, gene
writing, and epigenetic editing. The company is building out its
pipeline of potential in vivo gene editing therapeutics and
capabilities and has partnerships with leading pharmaceutical and
biotechnology companies to broaden the reach of its innovative and
proprietary technology. Mammoth's deep science and industry
experience, along with a robust and differentiated intellectual
property portfolio, have enabled the company to further its mission
to transform the lives of patients and deliver on the full promise
of CRISPR technologies.It is our policy and intent to provide equal
opportunity to all persons without regard to race, color, religion,
political affiliation, sex/gender (including gender
expression/identity, pregnancy, childbirth and related medical
conditions), marital status, registered domestic partner status,
sexual orientation, age, ancestry, national origin, veteran status,
disability, medical condition, genetic characteristics, and/or any
other basis protected by law. This policy covers all facets of
employment including, but not limited to: recruitment, selection,
placement, promotions, transfers, demotions, terminations,
training, and compensation.Mammoth Biosciences requires that all
employees be vaccinated against COVID-19 as a condition of at-will
employment, with exceptions for medical or religious reasons in
compliance with local, state, and federal law.
PI95c775c2d45f-25660-34240164
Keywords: Mammoth Biosciences, Newark , Director/Senior Director, Regulatory Affairs, Therapeutics, Executive , Brisbane, California
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