Senior Principal Scientist Toxicology
Company: Sanofi
Location: San Francisco
Posted on: June 26, 2022
Job Description:
As a toxicologist at Sanofi you would have the chance to develop
your skills and work across various modalities, including
Biologics, small molecules, mRNA, cell therapy, and gene therapy.
The position will concentrate on developing safety strategies and
successfully moving products into clinical development.Reporting to
the Head of Preclinical project in the US., this position will
provide the department of Preclinical Safety a wide range of
scientific expertise associated with Toxicology and Safety
Pharmacology needs on Discovery and Development Project Teams of
Sanofi Group. This position would provide toxicology scientific
expertise across the drug discovery and development value chain on
biotherapeutics and small molecules. This position is based in
Framingham, but will be moving to Cambridge MA in 2022. Position
can also be based out of San Francisco, CA.Key Responsibilities
- Serve as Preclinical Safety project team representative on
multi-disciplinary Discovery and Development teams responsible for
the progression of both biotherapeutics and small molecule
compounds for regulatory submissions. These activities include
designing and coordinating a multi-disciplinary effort to support
such projects through the development of the nonclinical safety
strategy and program which includes, but is not limited to
attending various project team meetings; the design and
interpretation of toxicity studies; the preparation and/or review
of written safety pharmacology and toxicology reports; and the
authoring of the nonclinical document sections for regulatory
submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs)
- Interact with multiple functions (Pharmacology, Regulatory
Affairs, Clinical, Project Leaders & Managers, etc.) on a daily
basis
- Participate in issue-resolution teams, where she/he will be
required to contribute to hypotheses generation and drive the
science for toxicology issue resolution in drug discovery and
development.
- Participate in Preclinical safety-US and global Preclinical
safety department activities (staff meeting, scientific forums,
etc.), and special projects
- Participate in special projects or inter-industry working
groups, as needed.
- Provide scientific input on design and analysis of research
activities
- Serve as internal expert for scientific issues related to
nonclinical safety issues
- Ensure high scientific standards and adhering to requested
timelines in all aspects of the positionBasic Qualifications:
- PhD in toxicology, pharmacology, immunology or related
disciplines with a minimum of 7 years of experience
- Minimum of 5 years of relevant industry experience
- Knowledgeable about GLP policies and/or regulatory nonclinical
testing requirements for pharmaceutical development of
biotherapeutics and small molecules
- Preparation of regulatory documents for submission to health
authorities
- Excellent verbal and written communication skills
- Demonstrate leadership and expertise in preclinical safety
disciplinesPreferred Qualifications:
- Knowledge in biochemistry, toxicology, pharmacology,
Immunology, physiology, and statistics.
- DABT certification is preferred, but not required.
- Experience as a GLP Study Director is preferred.At Sanofi
R&D North America, we deliver meaningful solutions for
patients. We transform science into breakthrough, best-in-class and
first-in-class medicines and vaccines. We believe in creating a
diverse and inclusive workforce - and workplace - which brings
together the collective brainpower of over 2,000 colleagues and
provides you with an exciting place to grow and develop. We set the
bar high, and we deliver. Join us and together we will build on our
trusted legacy of breakthroughs for society.Sanofi Inc. and its
U.S. affiliates are Equal Opportunity and Affirmative Action
employers committed to a culturally diverse workforce. All
qualified applicants will receive consideration for employment
without regard to race; color; creed; religion; national origin;
age; ancestry; nationality; marital, domestic partnership or civil
union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.As a healthcare company and a
vaccine manufacturer, Sanofi has an important responsibility to
protect individual and public health. All US based roles require
individuals to be fully vaccinated against COVID-19 as part of your
job responsibilities.According to the CDC, an individual is
considered to be "fully vaccinated" fourteen (14) days after
receiving (a) the second dose of the Moderna or Pfizer vaccine, or
(b) the single dose of the J&J vaccine. Fully vaccinated, for
new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO
START DATE.#GD-SA
#LI-SAPDNAt Sanofi diversity and inclusion is foundational to how
we operate and embedded in our Core Values. We recognize to truly
tap into the richness diversity brings we must lead with inclusion
and have a workplace where those differences can thrive and be
leveraged to empower the lives of our colleagues, patients and
customers. We respect and celebrate the diversity of our people,
their backgrounds and experiences and provide equal opportunity for
all.
Keywords: Sanofi, San Francisco , Senior Principal Scientist Toxicology, Other , San Francisco, California
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