Director/Senior Director, Regulatory Affairs, Therapeutics
Company: Mammoth Biosciences
Location: Brisbane
Posted on: May 17, 2024
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Job Description:
Mammoth BioSciencesOPPORTUNITYMammoth is hiring a Director/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 ClinicalPREFERRED
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 - $260,000The listed
base salary range is for Mammoth employees in the Bay Area. Actual
base salary will be determined by geographic work location,
relevant professional experience, applicable skills, and internal
equity. The base salary range for those working remotely outside of
the San Francisco Bay Area may differ and will be determined by
industry market data for the role and specific
region.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. PI1ef19bde968c-25660-34240164
Keywords: Mammoth Biosciences, San Francisco , Director/Senior Director, Regulatory Affairs, Therapeutics, Executive , Brisbane, California
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